Publications by authors named "Stéphanie Ragot"

100 Publications

Discontinuation of Imatinib in Children with Chronic Myeloid Leukemia: A Study from the International Registry of Childhood CML.

Cancers (Basel) 2021 Aug 15;13(16). Epub 2021 Aug 15.

Belarusian Research Centre for Pediatric Oncology, Hematology and Immunology, 223053 Minsk, Belarus.

Within the International Registry of Childhood Chronic Myeloid Leukemia (CML), we identified 18 patients less than 18 years old at diagnosis of CML who were in the chronic phase and exhibiting a sustained deep molecular response (DMR) to imatinib defined as BCR-ABL1/ABL1 < 0.01% (MR) for at least two years followed by discontinuation of imatinib. Before discontinuation, the median duration of imatinib was 73.2 months (range, 32-109) and the median duration of MR was 46.2 months (range, 23.9-98.6). Seven patients experienced loss of major molecular response (MMR) 4.1 months (range, 1.9-6.4) after stopping and so restarted imatinib. The median molecular follow-up after discontinuation was 51 months (range, 6-100) for the nine patients without molecular relapse. The molecular free remission rate was 61% (95% CI, 38-83%), 56% (95% CI, 33-79%) and 56% (95% CI, 33-79%) at 6, 12 and 36 months, respectively. Six of the seven children who experienced molecular relapse after discontinuation regained DMR (median, 4.7 months; range, 2.5-18) after restarting imatinib. No withdrawal syndrome was observed. In univariate analysis, age, sex, Sokal and ELTS scores, imatinib treatment and DMR durations before discontinuation had no influence on treatment free remission. These data suggest that imatinib can be safely discontinued in children with sustained MR for at least two years.
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http://dx.doi.org/10.3390/cancers13164102DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8392145PMC
August 2021

Benefit of Simulation-Based Training in Medical Adverse Events Disclosure in Pediatrics.

Pediatr Emerg Care 2021 May 18. Epub 2021 May 18.

From the Pediatric Emergency Department Statistical Department and Clinical Investigation Center (CIC 1402), INSERM (French National Health and Medical Research Institute), University Hospital of Poitiers ABS Lab, Simulation Laboratory, Faculty of Medicine, University of Poitiers, Poitiers Emergency Department and Emergency Medical Service, University Hospital of Bichat Infection Antimicrobials Modelling Evolution (IAME) research center, UMR 1137-INSERM, Faculty of Medicine of Paris-Diderot, Paris, France.

Introduction: Adverse events (AEs) in health care are a public health issue. Although mandatory, error disclosure is experienced by health providers as a difficult task.

Methods: In this prospective study, the primary objective was to assess performance in disclosing AEs to simulated parents using a validated scale before and after training among a pediatric residents' population. Secondary objectives were to assess correlation with year of residency, sex, and previous experience and to analyze gain in knowledge (theoretical pretest/posttest scores) and satisfaction. Two evaluation simulations (simulation [SIM] 1 and SIM 2) were scheduled at 3-week interval. In the intervention group, mastery learning was offered after SIM 1 including a didactic approach and a training session using role-playing games. For the control group, the course was carried out after SIM 2. Assessments were performed by 2 independent observers and simulated parents.

Results: Forty-nine pediatric residents performed 2 scenarios of AE disclosure in front of simulated parents. In the intervention group, performance scores on SIM 2 (72.36 ± 5.40) were higher than on SIM 1 (65.08 ± 9.89, P = 0.02). In the control group, there was no difference between SIM 1 and SIM 2 (P = 0.62). The subjective scores from simulated parents showed the same increase on SIM 2 (P < 0.01). There was no correlation with the residents' previous experience or their residency year. There was an increase in self-confidence (P = 0.04) for SIM 2. There was also an increase in posttest theoretical scores (P = 0.02), and residents were satisfied with the training.

Conclusions: This study showed the benefits of simulation-based training associated with mastery learning in AE disclosure among pediatric residents. It is important to train residents for these situations to avoid traumatic disclosure generating a loss of confidence of the family regarding physicians and possible lawsuits.
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http://dx.doi.org/10.1097/PEC.0000000000002454DOI Listing
May 2021

Noninvasive ventilation vs. high-flow nasal cannula oxygen for preoxygenation before intubation in patients with obesity: a post hoc analysis of a randomized controlled trial.

Ann Intensive Care 2021 Jul 22;11(1):114. Epub 2021 Jul 22.

Médecine Intensive Réanimation, CHU de Poitiers, Poitiers, France.

Background: Critically ill patients with obesity may have an increased risk of difficult intubation and subsequent severe hypoxemia. We hypothesized that pre-oxygenation with noninvasive ventilation before intubation as compared with high-flow nasal cannula oxygen may decrease the risk of severe hypoxemia in patients with obesity.

Methods: Post hoc subgroup analysis of critically ill patients with obesity (body mass index ≥ 30 kg·m) from a multicenter randomized controlled trial comparing preoxygenation with noninvasive ventilation and high-flow nasal oxygen before intubation of patients with acute hypoxemic respiratory failure (PaO/FiO < 300 mm Hg). The primary outcome was the occurrence of severe hypoxemia (pulse oximetry < 80%) during the intubation procedure.

Results: Among the 313 patients included in the original trial, 91 (29%) had obesity with a mean body mass index of 35 ± 5 kg·m. Patients with obesity were more likely to experience an episode of severe hypoxemia during intubation procedure than patients without obesity: 34% (31/91) vs. 22% (49/222); difference, 12%; 95% CI 1 to 23%; P = 0.03. Among patients with obesity, 40 received preoxygenation with noninvasive ventilation and 51 with high-flow nasal oxygen. Severe hypoxemia occurred in 15 patients (37%) with noninvasive ventilation and 16 patients (31%) with high-flow nasal oxygen (difference, 6%; 95% CI - 13 to 25%; P = 0.54). The lowest pulse oximetry values during intubation procedure were 87% [interquartile range, 77-93] with noninvasive ventilation and 86% [78-92] with high-flow nasal oxygen (P = 0.98). After multivariable analysis, factors independently associated with severe hypoxemia in patients with obesity were intubation difficulty scale > 5 points and respiratory primary failure as reason for admission.

Conclusions: Patients with obesity and acute hypoxemic respiratory failure had an increased risk of severe hypoxemia during intubation procedure as compared to patients without obesity. However, preoxygenation with noninvasive ventilation may not reduce this risk compared with high-flow nasal oxygen. Trial registration Clinical trial number: NCT02668458 ( http://www.clinicaltrials.gov ).
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http://dx.doi.org/10.1186/s13613-021-00892-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295638PMC
July 2021

Intraglomerular dysfunction predicts kidney failure in type 2 diabetes.

Diabetes 2021 Jul 13. Epub 2021 Jul 13.

University of Colorado, Denver, CO USA

No longitudinal data link intraglomerular hemodynamic dysfunction with end-stage kidney disease (ESKD) in people with type 2 diabetes (T2D). Afferent (R) and efferent (R) arteriolar tone and intraglomerular pressure (P) are not directly measurable in humans but are estimable from glomerular filtration rate (GFR), renal plasma flow (RPF), blood pressure, hematocrit, and plasma oncotic pressure. We examined the association of the R/R ratio and P with ESKD incidence in 237 Pima Indian persons with T2D who underwent serial measures of GFR (iothalamate) and RPF (-aminohippurate). Their association with kidney structural lesions was also examined in a subset of 111 participants. Of the 237 participants (mean age 42 years, diabetes duration 11 years, GFR 153 ml/min, median ACR 36 mg/g), 69 progressed to ESKD during median follow-up of 17.5 years. In latent class analysis, distinct trajectories characterized by increasing R/R ratio (HR: 4.60, 95% CI 2.55-8.31) or elevated P followed by a rapid decline (HR: 2.96, 95% CI 1.45-6.02) strongly predicted incident ESKD. P (R=21%, p<0.0001) and R/R (R=15%, p<0.0001) also correlated with mesangial fractional volume, a structural predictor of DKD progression.In conclusion, intraglomerular hemodynamic parameters associated strongly with incident ESKD and correlated with structural lesions of DKD.
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http://dx.doi.org/10.2337/db21-0154DOI Listing
July 2021

Non-invasive ventilation versus high-flow nasal oxygen for postextubation respiratory failure in ICU: a post-hoc analysis of a randomized clinical trial.

Crit Care 2021 06 28;25(1):221. Epub 2021 Jun 28.

Centre Hospitalier Universitaire de Poitiers, Service de Médecine Intensive Réanimation, Médecine Intensive Réanimation, 2 rue la Milétrie, 86021, Poitiers Cedex, France.

Background: In intensive care units (ICUs), patients experiencing post-extubation respiratory failure have poor outcomes. The use of noninvasive ventilation (NIV) to treat post-extubation respiratory failure may increase the risk of death. This study aims at comparing mortality between patients treated with NIV alternating with high-flow nasal oxygen or high-flow nasal oxygen alone.

Methods: Post-hoc analysis of a multicenter, randomized, controlled trial focusing on patients who experienced post-extubation respiratory failure within the 7 days following extubation. Patients were classified in the NIV group or the high-flow nasal oxygen group according to oxygenation strategy used after the onset of post-extubation respiratory failure. Patients reintubated within the first hour after extubation and those promptly reintubated without prior treatment were excluded. The primary outcome was mortality at day 28 after the onset of post-extubation respiratory failure.

Results: Among 651 extubated patients, 158 (25%) experienced respiratory failure and 146 were included in the analysis. Mortality at day 28 was 18% (15/84) using NIV alternating with high-flow nasal oxygen and 29% (18/62) with high flow nasal oxygen alone (difference, - 11% [95% CI, - 25 to 2]; p = 0.12). Among the 46 patients with hypercapnia at the onset of respiratory failure, mortality at day 28 was 3% (1/33) with NIV and 31% (4/13) with high-flow nasal oxygen alone (difference, - 28% [95% CI, - 54 to - 6]; p = 0.006). The proportion of patients reintubated 48 h after the onset of post-extubation respiratory failure was 44% (37/84) with NIV and 52% (32/62) with high-flow nasal oxygen alone (p = 0.21).

Conclusions: In patients with post-extubation respiratory failure, NIV alternating with high-flow nasal oxygen might not increase the risk of death. Trial registration number The trial was registered at http://www.clinicaltrials.gov with the registration number NCT03121482 the 20th April 2017.
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http://dx.doi.org/10.1186/s13054-021-03621-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8236736PMC
June 2021

Sleep deprivation reduces vagal tone during an inspiratory endurance task in humans.

Sleep 2021 Apr 25. Epub 2021 Apr 25.

Centre d'Investigation Clinique Inserm, Team Acute Lung Injury and VEntilatory support, Centre Hospitalier Universitaire de Poitiers, France.

Study Objectives: Sleep deprivation alters inspiratory endurance by reducing inspiratory motor output. Vagal tone is involved in exercise endurance. This study aimed to investigate the effect of sleep deprivation on vagal tone adaptation in healthy subjects performing an inspiratory effort.

Methods: Vagal tone was assessed using Heart Rate Variability normalized units of frequency domain component HF (high frequency) before, at the start, and the end of an inspiratory loading trial performed until exhaustion by 16 volunteers after one night of sleep deprivation and one night of normal sleep, where sleep deprivation reduced the inspiratory endurance by half compared to the normal sleep condition (30min vs 60 min).

Results: At rest, heart rate was similar in sleep deprivation and normal sleep conditions. In normal sleep condition, heart rate increased during inspiratory loading task; this increase was greater in sleep deprivation condition. In normal sleep condition, vagal tone increased at the beginning of the trial. This vagal tone increase was absent in sleep deprivation condition.

Conclusions: Sleep deprivation abolished vagal tone response to inspiratory load, possibly contributing to a higher heart rate during the trial and to a reduced inspiratory endurance.
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http://dx.doi.org/10.1093/sleep/zsab105DOI Listing
April 2021

A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery (INSTRUMODA).

BMC Pregnancy Childbirth 2021 Mar 25;21(1):251. Epub 2021 Mar 25.

Poitiers University Hospital, Department of Obstetrics and Gynecology, Poitiers, France.

Background: We aimed at developing a core outcome and variables of interest set to investigate the effects of mediolateral episiotomy on Obstetric Anal Sphincter Injury (OASI) during and after operative delivery in nulliparous women in a large-scale one-year observational French study including 15,000 women (INSTRUMODA).

Methods: A list of outcomes and variables of interest was suggested to obstetricians participating in the INSTRUMODA study using online questionnaires divided into 7 categories: the woman's history and course of pregnancy, course of labor, modalities of operative delivery, episiotomy characteristics, immediate maternal morbidity, one-year maternal morbidity, immediate neonatal morbidity. We used a three-round DELPHI method to reach a consensus. In the first round, outcomes and variables considered as essential by 70% or more of obstetricians were included in the corpus whereas they were excluded when 70% rated them as "not important". In the second round, non-consensual outcomes and variables were reassessed and excluded or definitively included if considered as "not important" or essential by 50% or more of the obstetricians. During the first round, obstetricians were invited to suggest new outcomes and/or variables that were then assessed in the second and third round. We used the same method to develop a core outcome and variables of interest set in a population of women in the community recruited via an association of patients. At the end of the procedure the core outcome and variables of interest sets were merged to provide the final core outcome set for the INSTRUMODA study.

Results: Fifty-three obstetricians and 16 women filled out questionnaires. After the 3 rounds of Delphi procedure in each population, 74 outcomes and variables were consensually reported by obstetricians and 92 by women in the community. By mixing these two consensual corpora we reported a final consensual list of 114 variables of interest and outcomes for both obstetricians and women.

Conclusion: We established a core outcome and variables of interest set among obstetricians and women in the community to investigate the association between mediolateral episiotomy and OASI during operative delivery.

Trial Registration: The INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 ( NCT04446780 ).
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http://dx.doi.org/10.1186/s12884-021-03603-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7993449PMC
March 2021

Non-invasive ventilation alternating with high-flow nasal oxygen versus high-flow nasal oxygen alone after extubation in COPD patients: a post hoc analysis of a randomized controlled trial.

Ann Intensive Care 2021 Feb 9;11(1):30. Epub 2021 Feb 9.

Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.

Background: Several randomized clinical trials have shown that non-invasive ventilation (NIV) applied immediately after extubation may prevent reintubation in patients at high-risk of extubation failure. However, most of studies included patients with chronic respiratory disorders as well as patients without underlying respiratory disease. To date, no study has shown decreased risk of reintubation with prophylactic NIV after extubation among patients with chronic obstructive pulmonary disease (COPD). We hypothesized that prophylactic NIV after extubation may decrease the risk of reintubation in COPD patients as compared with high-flow nasal oxygen. We performed a post hoc subgroup analysis of COPD patients included in a multicenter, randomized, controlled trial comparing prophylactic use of NIV alternating with high-flow nasal oxygen versus high-flow nasal oxygen alone immediately after extubation.

Results: Among the 651 patients included in the original study, 150 (23%) had underlying COPD including 86 patients treated with NIV alternating with high-flow nasal oxygen and 64 patients treated with high-flow nasal oxygen alone. The reintubation rate was 13% (11 out of 86 patients) with NIV and 27% (17 out of 64 patients) with high-flow nasal oxygen alone [difference, - 14% (95% CI - 27% to - 1%); p = 0.03]. Whereas reintubation rates were significantly lower with NIV than with high-flow nasal oxygen alone at 72 h and until ICU discharge, mortality in ICU did not differ between groups: 6% (5/86) with NIV vs. 9% (6/64) with high-flow nasal oxygen alone [difference - 4% (95% CI - 14% to 5%); p = 0.40].

Conclusions: In COPD patients, prophylactic NIV alternating with high-flow nasal oxygen significantly decreased the risk of reintubation compared with high-flow nasal oxygen alone. Trial registration The study was registered at http://www.clinicaltrials.gov with the trial registration number NCT03121482 (20 April 2017).
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http://dx.doi.org/10.1186/s13613-021-00823-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7871306PMC
February 2021

Predicting response to a community-based educational workshop on incontinence among community-dwelling older women: Post hoc analysis of the CACTUS-D trial.

Neurourol Urodyn 2021 02 5;40(2):705-713. Epub 2021 Feb 5.

University of Alberta, Edmonton, Alberta, Canada.

Aims: Our goal was to identify which women participating in an educational workshop on incontinence were most likely to benefit from it.

Methods: We included women aged 65 or older, living in the community, and not treated for incontinence despite reporting urinary leakage at least twice a week. The workshop's aims were to change beliefs about accepting incontinence as a normal part of ageing, explain that incontinence is not irreversible, and that solutions exist. We performed structured interviews at 6 and 12 months to assess impressions of improvement (PGI-I) and changes in both continence (ICIQ-FLUTS) and quality of life (I-QOL).

Results: The analysis included 392 women, 39% aged 80 or older and 57% with daily urinary incontinence. Twelve months after the workshop, 16% of women were "much better" (PGI-I); factors associated with impression of improvement were refusal to believe that incontinence is part of normal ageing at baseline and improvement of urinary symptoms. The median improvement was 4 points on the ICIQ-FLUTS and 8 on the I-QOL. Factors associated with a clinically significant improvement in urinary symptoms were more severe baseline urinary incontinence, obesity, and starting Kegel exercises. Factors associated with a clinically significant improvement in quality of life were a poor urinary quality of life at baseline and an age younger than 81 years.

Conclusions: A short, inexpensive and nonmedical intervention can change the mind-set and behavior of older women with incontinence who are not seeking care. A clinically significant improvement is possible even in women with severe symptoms.
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http://dx.doi.org/10.1002/nau.24614DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247852PMC
February 2021

Plasma concentrations of lipoproteins and risk of lower-limb peripheral artery disease in people with type 2 diabetes: the SURDIAGENE study.

Diabetologia 2021 Mar 6;64(3):668-680. Epub 2021 Jan 6.

Département d'Endocrinologie, Diabétologie, Nutrition, Hôpital Haut-Lévêque, Pessac, Bordeaux, France.

Aims/hypothesis: The lipid profile has not been fully investigated in individuals with peripheral artery disease (PAD). We aimed to evaluate the relationship between plasma concentrations of lipoproteins and the prevalence of lower-limb PAD at baseline and its incidence during follow-up in people with type 2 diabetes.

Methods: Plasma concentrations of total cholesterol, HDL-cholesterol, triacylglycerol and apolipoprotein (Apo) A-I, ApoA-II, ApoB-100 and Apo(a) were measured at baseline using colorimetric or MS methods in the SURDIAGENE cohort. Total cholesterol/HDL-cholesterol ratio, non-HDL-cholesterol and LDL-cholesterol were estimated using computation formulas. Logistic and Cox proportional hazard regression models were fitted to estimate OR or HR, with related 95% CI, for baseline prevalence or incidence of major PAD (lower-limb amputation or requirement of revascularisation) during follow-up by increasing lipoprotein tertiles, after adjustment for key confounders.

Results: Among 1468 participants (women 42%, mean ± SD age 65 ± 11 years, duration of diabetes 14 ± 10 years at baseline), 129 (8.8%) had a baseline history of major PAD. Major PAD was less prevalent at baseline in the highest (vs lowest) tertile of HDL-cholesterol (OR 0.42 [95% CI 0.26, 0.71], p = 0.001) and ApoA-I (OR 0.39 [95% CI 0.23, 0.67], p = 0.0007), and more frequent in the highest tertile of total cholesterol/HDL-cholesterol ratio (OR 1.95 [95% CI 1.18, 3.24], p = 0.01). Among 1339 participants without a history of PAD at baseline, incident PAD occurred in 97 (7.2%) during a median (25th-75th percentile) duration of follow-up of 7.1 (4.4-10.7) years, corresponding to 9685 person-years and an incidence rate of 9.8 (95% CI 8.0, 12.0) per 1000 person-years. The risk of incident PAD was lower in the top (vs bottom) tertile of HDL-cholesterol (HR 0.54 [95% CI 0.30, 0.95], p = 0.03) or ApoA-I (HR 0.50 [95% CI 0.28, 0.86], p = 0.01) and higher in the top tertile of total cholesterol/HDL-cholesterol ratio (HR 2.81 [95% CI 1.61, 5.04], p = 0.0002) and non-HDL-cholesterol (HR 1.80 [95% CI 1.06, 3.12], p = 0.03).

Conclusions/interpretation: We reported independent associations between HDL-cholesterol, ApoA-I, total cholesterol/HDL-cholesterol ratio or non-HDL-cholesterol and the prevalence or the incidence of major PAD in people with type 2 diabetes. Our findings provide a picture of lipoprotein profile in people with type 2 diabetes. Graphical abstract.
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http://dx.doi.org/10.1007/s00125-020-05326-xDOI Listing
March 2021

Skin inflammatory response and efficacy of anti-epidermal growth factor receptor therapy in metastatic colorectal cancer (CUTACETUX).

Oncoimmunology 2020 11 29;9(1):1848058. Epub 2020 Nov 29.

Laboratory Inflammation, Tissus Epithéliaux Et Cytokines, EA 4331, Poitiers University, Poitiers, France.

Anti-epidermal growth factor receptor (EGFR) monoclonal antibody is a standard treatment of metastatic colorectal cancer (mCRC) and its most common adverse effect is a papulopustular acneiform rash. The aim of the CUTACETUX study was to characterize the skin inflammatory response associated with this rash and its relation to treatment efficacy. This prospective study included patients with mCRC treated with first-line chemotherapy plus cetuximab. Patients underwent skin biopsies before the initiation of cetuximab (D0) and before the third infusion (D28), one in a rash zone and one in an unaffected zone. Expression of Th17-related cytokines (IL-17A, IL-21, IL-22), antimicrobial peptides (S100A7 and BD-2), innate response-related cytokines (IL-1β, IL-6, TNF-α and OSM), T-reg-related cytokines (IL-10 and TGF-β), Th1-related cytokine (IFN-γ), Th2-related cytokine (IL-4), Thymic stromal lymphopoietin and keratinocyte-derived cytokines (IL-8, IL-23 and CCL20) were determined by RT-PCR. Twenty-seven patients were included. Levels of most of the cytokines increased at D28 in the rash zone compared to D0. No significant association was observed between variations of cytokines levels and treatment response in the rash zone and only the increase of IL-4 ( = .04) and IL-23 ( = .02) levels between D0 and D28 in the unaffected zone was significantly associated with treatment response. Increased levels of IL-8 ( = .02), BD-2 ( = .02), IL-1β ( = .004) and OSM ( = .02) in the rash zone were associated with longer progression-free survival. Expression of Th2-related and keratinocyte-derived cytokines in the skin was associated with anti-EGFR efficacy. If this inflammatory signature can explain the rash, the exact mechanism by which these cytokines are involved in anti-EGFR tumor response remains to be studied.
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http://dx.doi.org/10.1080/2162402X.2020.1848058DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7714491PMC
November 2020

T-piece versus pressure-support ventilation for spontaneous breathing trials before extubation in patients at high risk of reintubation: protocol for a multicentre, randomised controlled trial (TIP-EX).

BMJ Open 2020 11 24;10(11):e042619. Epub 2020 Nov 24.

Service de Médecine Intensive et Réanimation, Centre Hospitalier Departmental La Roche-sur-Yon, La Roche-sur-Yon, Pays de la Loire, France.

Introduction: In intensive care unit (ICU), the decision of extubation is a critical time because mortality is particularly high in case of reintubation. To reduce that risk, guidelines recommend to systematically perform a spontaneous breathing trial (SBT) before extubation in order to mimic the postextubation physiological conditions. SBT is usually performed with a T-piece disconnecting the patient from the ventilator or with low levels of pressure-support ventilation (PSV). However, work of breathing is lower during PSV than during T-piece. Consequently, while PSV trial may hasten extubation, it may also increase the risk of reintubation. We hypothesise that, compared with T-piece, SBT performed using PSV may hasten extubation without increasing the risk of reintubation.

Methods And Analysis: This study is an investigator-initiated, multicentre randomised controlled trial comparing T-piece vs PSV for SBTs in patients at high risk of reintubation in ICUs. Nine hundred patients will be randomised with a 1:1 ratio in two groups according to the type of SBT. The primary outcome is the number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation between the initial SBT (day 1) and day 28. Secondary outcomes include the number of days between the initial SBT and the first extubation attempt, weaning difficulty, the number of patients extubated after the initial SBT and not reintubated within the following 72 hours, the number of patients extubated within the 7 days following the initial SBT, the number of patients reintubated within the 7 days following extubation, in-ICU length of stay and mortality in ICU, at day 28 and at day 90.

Ethics And Dissemination: The study has been approved by the central ethics committee 'Ile de France V' (2019-A02151-56) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial Registration Number: NCT04227639.
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http://dx.doi.org/10.1136/bmjopen-2020-042619DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7689072PMC
November 2020

Sleep Deprivation Increases Air Hunger rather than Breathing Effort.

Am J Respir Crit Care Med 2021 03;203(5):642-645

Université de Poitiers Poitiers, France.

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http://dx.doi.org/10.1164/rccm.202004-1478LEDOI Listing
March 2021

Relationship Between Diabetic Retinopathy Stages and Risk of Major Lower-Extremity Arterial Disease in Patients With Type 2 Diabetes.

Diabetes Care 2020 11 2;43(11):2751-2759. Epub 2020 Sep 2.

Hôpital Haut-Lévêque, Département d'Endocrinologie, Diabétologie, Nutrition, Pessac, Bordeaux, France

Objective: We evaluated the association between diabetic retinopathy stages and lower-extremity arterial disease (LEAD), its prognostic value, and the influence of potential contributors to this relationship in a prospective cohort of patients with type 2 diabetes.

Research Design And Methods: Diabetic retinopathy was staged at baseline as absent, nonproliferative, or proliferative. A Cox regression model was fitted in order to compute the hazard ratio (HR) (95% CI) for major LEAD (lower-limb amputation or revascularization) during follow-up by baseline retinopathy stages. The retinopathy-LEAD association was assessed in subgroups by age, sex, diabetes duration, HbA, systolic blood pressure, diabetic kidney disease, smoking, and macrovascular disease at baseline. The performance of retinopathy in stratifying LEAD risk was assessed by using the C statistic, integrated discrimination improvement (IDI), and net reclassification improvement (NRI).

Results: Among 1,320 participants without a history of LEAD at baseline, 94 (7.1%) developed a major LEAD during a 7.1-year median follow-up (incidence rate 9.6 per 1,000 person-years [95% CI 7.8-11.7]). The LEAD incidence rate (per 1,000 person-years) increased as retinopathy worsened: it was 5.5 (95% CI 3.9-7.8) in participants in whom retinopathy was absent, 14.6 (11.1-19.3) in those with nonproliferative retinopathy, and 20.1 (11.1-36.3) in those with proliferative retinopathy. Nonproliferative retinopathy (adjusted HR 2.31 [95% CI 1.43-3.81], = 0.0006) and proliferative retinopathy (3.14 [1.40-6.15], = 0.007) remained associated with major LEAD. No heterogeneity was observed across subgroups. Retinopathy enhanced the C statistic (+0.023 [95% CI 0.003-0.044], = 0.02), IDI (0.209 [0.130-0.321], < 0.001), and NRI (0.562 [0.382-0.799], < 0.001) values for risk of LEAD, beyond traditional risk factors.

Conclusions: An independent dose-response relationship was identified between diabetic retinopathy stages and major LEAD. Retinopathy yielded incremental prognostic information for stratifying risk of LEAD, suggesting its usefulness as a predictor of LEAD.
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http://dx.doi.org/10.2337/dc20-1085DOI Listing
November 2020

Should autism spectrum disorder be considered part of CHARGE syndrome? A cross-sectional study of 46 patients.

Orphanet J Rare Dis 2020 06 3;15(1):136. Epub 2020 Jun 3.

Faculty of Medicine, University of Paris, Paris, France.

Background: Behavioral problems are an important issue for people with CHARGE syndrome. The similarity of their behavioral traits with those of people with autism raises questions. In a large national cross-sectional study, we used specific standardized tools for diagnosing autism (Autism Diagnostic Interview-Revised and Diagnostic and Statistical Manual of Mental Disorders, 5th edition, DSM-5) and evaluating behavioral disorders (Developmental Behavior Checklist-Parents, DBC-P) to investigate a series of individuals with CHARGE syndrome, defined by Verloes's criteria. We evaluated their adaptive functioning level and sensory particularities and extracted several data items from medical files to assess as potential risk factors for autism and/or behavioral disorders.

Results: We investigated 64 individuals with CHARGE syndrome (35 females; mean age 10.7 years, SD 7.1 years). Among 46 participants with complete results for the Autism Diagnostic Interview-Revised (ADI-R), 13 (28%) had a diagnosis of autism according to the ADI-R, and 25 (54%) had a diagnosis of autism spectrum disorder (ASD) according to the DSM-5 criteria. The frequency of autistic traits in the entire group was a continuum. We did not identify any risk factor for ASD but found a negative correlation between the ADI-R score and adaptive functioning level. Among 48 participants with data for the DBC-P, 26 (55%) had behavioral disorders, which were more frequent in patients with radiological brain anomalies, impaired adaptive functioning, later independent walking, and more sensory particularities.

Conclusions: ASD should be considered to be an independent risk requiring early screening and management in children born with CHARGE syndrome.
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http://dx.doi.org/10.1186/s13023-020-01421-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7268350PMC
June 2020

Low-dose tyrosine kinase inhibitors before treatment discontinuation do not impair treatment-free remission in chronic myeloid leukemia patients: Results of a retrospective study.

Cancer 2020 08 27;126(15):3438-3447. Epub 2020 May 27.

Service de Cancérologie Biologique, CHU Poitiers, Poitiers, France.

Background: Long-term treatment-free remission (TFR) represents a new goal for chronic myeloid leukemia (CML). In clinical practice, tyrosine kinase inhibitor (TKI) dose reductions can be considered a means of preventing adverse effects and improving quality of life. We hypothesized that administration of low-dose TKIs before treatment discontinuation does not impair TFR in patients with CML who have a deep molecular response (DMR, ≥MR ).

Methods: We conducted a retrospective analysis of 77 patients with CML who discontinued treatment with TKIs. Twenty-six patients had been managed with low-dose TKIs before stopping treatment. Patients were to be exposed to TKIs for ≥5 years and to low-dose TKIs for ≥1 year and in DMR for ≥2 years. The loss of major molecular response (MMR) was considered a trigger for restarting therapy.

Results: In the low-dose group, 61.5% of patients received second-generation TKIs, and dose reduction was ≥50% for 65.4% of patients. With a median follow-up of 61.5 months, TFR at 12 months was 56.8% in the full-dose TKI group and 80.8% in the low-dose group, and TFR at 60 months was 47.5% and 58.8%, respectively. The median time to molecular recurrence (≥MMR) from TKI discontinuation in the entire cohort was 6.2 months. All patients quickly achieved MMR after resuming TKI therapy. Results appear independent of both dose reduction and potential pretreatment with interferon-α.

Conclusion: This retrospective study shows that TFR was not impaired by low-dose TKI regimens before TKI cessation in Patients with CML. Nevertheless, prospective randomized clinical trials must be undertaken to analyze the probability of successful TFR in patients managed with TKI dose de-escalation strategies before TKI discontinuation.
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http://dx.doi.org/10.1002/cncr.32940DOI Listing
August 2020

Pressure-Support Ventilation vs T-Piece During Spontaneous Breathing Trials Before Extubation Among Patients at High Risk of Extubation Failure: A Post-Hoc Analysis of a Clinical Trial.

Chest 2020 10 19;158(4):1446-1455. Epub 2020 May 19.

Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.

Background: Spontaneous breathing trial (SBT) using a T-piece remains the most frequently performed trial before extubation in ICUs.

Research Question: We aimed at determining whether initial SBT using pressure-support ventilation (PSV) could increase successful extubation rates among patients at high risk of extubation failure.

Study Design And Methods: Post hoc analysis of a multicenter trial focusing on reintubation in patients at high-risk of extubation failure. The initial SBT was performed using PSV or T-piece according to the physician/center decision. The primary outcome was the proportion of patients successfully extubated 72 hours after initial SBT, that is, extubated after initial SBT and not reintubated within the following 72 hours.

Results: Among the 641 patients included in the original study, initial SBT was performed using PSV (7.0 cm HO in median without positive end-expiratory pressure) in 243 patients (38%) and using a T-piece in 398 patients (62%). The proportion of patients successfully extubated 72 hours after initial SBT was 67% (162/243) using PSV and 56% (223/398) using T-piece (absolute difference 10.6%; 95% CI, 2.8 to 28.1; P = .0076). The proportion of patients extubated after initial SBT was 77% (186/283) using PSV and 63% (249/398) using T-piece (P = .0002), whereas reintubation rates within the following 72 hours did not significantly differ (13% vs 10%, respectively; P = .4259). Performing an initial SBT using PSV was independently associated with successful extubation (adjusted OR, 1.60; 95% CI, 1.30 to 2.18; P = .0061).

Interpretation: In patients at high risk of extubation failure in the ICU, performing an initial SBT using PSV may hasten extubation without an increased risk of reintubation.
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http://dx.doi.org/10.1016/j.chest.2020.04.053DOI Listing
October 2020

Plasma Trimethylamine N-Oxide and Risk of Cardiovascular Events in Patients With Type 2 Diabetes.

J Clin Endocrinol Metab 2020 07;105(7)

CRNH-O, Plateforme Spectrométrie de Masse (PFSM, Mass Spectrometry Core Facility), Nantes, France.

Objective: Even though trimethylamine N-oxide (TMAO) has been demonstrated to interfere with atherosclerosis and diabetes pathophysiology, the association between TMAO and major adverse cardiovascular events (MACE) has not been specifically established in type 2 diabetes (T2D).

Research Design And Methods: We examined the association of plasma TMAO concentrations with MACE and all-cause mortality in a single-center prospective cohort of consecutively recruited patients with T2D.

Results: The study population consisted in 1463 SURDIENE participants (58% men), aged 65 ± 10 years. TMAO concentrations were significantly associated with diabetes duration, renal function, high-density lipoprotein cholesterol, soluble tumor necrosis factor receptor 1 (sTNFR1) concentrations (R2 = 0.27) and were significantly higher in patients on metformin, even after adjustment for estimated glomerular filtration rate (eGFR): 6.7 (8.5) vs 8.5 (13.6) µmol/L, respectively (PeGFR-adjusted = 0.0207). During follow-up (median duration [interquartile range], 85 [75] months), 403 MACE and 538 deaths were registered. MACE-free survival and all-cause mortality were significantly associated with the quartile distribution of TMAO concentrations, patients with the highest TMAO levels displaying the greatest risk of outcomes (P < 0.0001). In multivariate Cox models, compared with patients from the first 3 quartiles, those from the fourth quartile of TMAO concentration had an independently increased risk for MACE: adjusted hazard ratio (adjHR) 1.32 (1.02-1.70); P = 0.0325. Similarly, TMAO was significantly associated with mortality in multivariate analysis: adjHR 1.75 (1.17-2.09); P = 0.0124, but not when sTNFR1 and angiopoietin like 2 were considered: adjHR 1.16 (0.95-1.42); P = 0.1514.

Conclusions: We revealed an association between higher TMAO concentrations and increased risk of MACE and all-cause mortality, thereby opening some avenues on the role of dysbiosis in cardiovascular risk, in T2D patients.
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http://dx.doi.org/10.1210/clinem/dgaa188DOI Listing
July 2020

Regulation of Protein Synthesis and Apoptosis in Lymphocytes of Parkinson Patients: The Effect of Dopaminergic Treatment.

Neurodegener Dis 2019 6;19(5-6):178-183. Epub 2020 Mar 6.

Faculté de Médecine-Pharmacie, Université de Poitiers, Poitiers, France.

Background: Parkinson disease (PD) is a neurodegenerative disorder characterized by progressive degeneration of the dopaminergic neurons in the substantia nigra, presumably due to increased apoptosis. In previous studies, we showed altered expression of proteins involved in mammalian target of rapamycin (mTOR) antiapoptotic and double-stranded RNA-dependent protein kinase (PKR) apoptotic pathways of translational control in experimental cellular and animal models of PD.

Results: In this work, our results showed clear modifications in the expression of kinases involved in mTOR and PKR apoptosis pathways, in lymphocytes of PD patients treated or not with anti-PD treatment (levodopa), which confirmed the role played by apoptosis in the pathogenesis of this disease and the positive effect of treatment with medication on this parameter. Others proteins involved in apo-ptosis were also evaluated in lymphocytes of patients as the expression of the peripheral benzodiazepine receptor and caspase-3.

Conclusion: Translational control is altered in PD and hence its evaluation in peripheral blood mononuclear cells may serve as an early marker of apoptosis and indicate the efficacy of the dopaminergic treatment.
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http://dx.doi.org/10.1159/000505750DOI Listing
September 2020

Strategies to Avoid Extubation Failure Among ICU Patients-Reply.

JAMA 2020 03;323(9):892-893

Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.

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http://dx.doi.org/10.1001/jama.2019.21954DOI Listing
March 2020

Frailty and diabetes status in older patients with cancer: impact on mortality in the ANCRAGE cohort.

Aging Clin Exp Res 2020 Sep 2;32(9):1809-1819. Epub 2020 Jan 2.

Department of Geriatrics, CHU Poitiers, 2 rue de la Milétrie, 86021, Poitiers Cedex, France.

Background: Frailty, diabetes and cancer are associated with aging, but the relationship between these conditions is not well defined.

Aims: We studied older patients with cancer from the prospective single-center cohort ANCRAGE (ANalyses of CanceR in AGEd) aiming to determine the impact of type 2 diabetes (T2D) and its vascular complications (VC) on frailty and adverse outcomes (mortality, unplanned readmission) during follow-up.

Methods: Analysis of cohort patients ≥ 75 years, included between 2009 and 2017, who underwent a comprehensive geriatric assessment (CGA). Variables of interest were history of T2D and VC, tumor site and metastatic status, CGA including eight domains (social environment, functional status, mobility, nutrition, mood, cognition, polypharmacy and comorbidities) and frailty.

Results: Among 1092 patients (47% female, mean age 82 ± 5 years), 219 (20%) had a reported diagnosis of T2D at baseline including 152 (69%) with VC. The most common tumor sites were prostate (15%), breast (15%), skin (12%), and colorectum (11%); 29% of patients had a metastatic disease. Frailty was highly prevalent (84%). During follow-up (median of 15.3 months), 653 (60%) patients died (60% no T2D, 43% T2D without VC, 66% with VC). After adjustment for age, gender and metastatic status, diabetics with VC had a higher risk of all-cause death (aHR1.89, 1.24-2.86, p = 0.004). Death was more frequently due to a non-cancer cause (p < 0.001). No difference in unplanned readmissions was observed in the three groups. Frailty was an independent risk factor for mortality and unplanned readmissions (p < 0.001 both).

Conclusion: In older cancer patients from the prospective ANCRAGE cohort, all-cause mortality was significantly higher in frail patients and those with complicated T2D, a finding questioning the quality of care management in such vulnerable patients, and stimulating further research in this multidisciplinary field.
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http://dx.doi.org/10.1007/s40520-019-01362-9DOI Listing
September 2020

Association between sleep disturbances, fear of hypoglycemia and psychological well-being in adults with type 1 diabetes mellitus, data from cross-sectional VARDIA study.

Diabetes Res Clin Pract 2020 Feb 19;160:107988. Epub 2019 Dec 19.

Institut MITOVASC, UMR CNRS 6015, INSERM 1083, Université d'Angers, 3 rue Roger Amsler, 49100 Angers, France; Diabetes Department, CHU d'Angers, 4 rue Larrey, 49100 Angers, France. Electronic address:

Aim: To assess the relationship between sleep quality, fear of hypoglycemia, glycemic variability and psychological well-being in type 1 diabetes mellitus.

Methods: Our data were provided by the VARDIA Study, a multicentric cross-sectional study conducted between June and December 2015. Sleep characteristics were assessed by the Pittsburgh Sleep Quality Index (PSQI). Fear of hypoglycemia and psychological well-being were measured with the Hypoglycemia Fear Survey version II (HFS-II) and the Hospital Anxiety and Depression Scale (HADS), respectively. Glycemic variability (GV) was determined using the CV of three 7-point self-monitoring blood glucose profiles and the mean amplitude of glycemic excursion (MAGE).

Results: 315 patients were eligible for PSQI questionnaire analysis: 54% women, mean age 47 ± 15, mean diabetes duration of 24 ± 13 years, HbA1c of 7.6 ± 0.9% (60 ± 7,5mmol/mol). Average PSQI score was 6.0 ± 3.3 and 59.8% of the patients had a PSQI score > 5. HFS-II score and HADS were significantly higher among "poor" sleepers (p < 0.0001) and PSQI score was positively associated with HADS (β = 0.22; 95% CI = 0.08;0.35). GV evaluated by CV or MAGE did not differ between "poor" and "good" sleepers (p = 0.28 and 0.54, respectively).

Conclusions: Adult patients with type 1 diabetes have sleep disturbances which correlate with psychological well-being. This study suggests that psychological management can be a target to improve sleep quality in adults with type 1 diabetes mellitus.
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http://dx.doi.org/10.1016/j.diabres.2019.107988DOI Listing
February 2020

Impact of Sleep Deprivation on Respiratory Motor Output and Endurance. A Physiological Study.

Am J Respir Crit Care Med 2020 04;201(8):976-983

INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.

Sleep deprivation can alter endurance of skeletal muscles, but its impact on respiratory command is unknown. We aimed to assess the effect of sleep deprivation on respiratory motor output and inspiratory endurance. Inspiratory endurance was investigated twice in random order, following a normal sleep night and a sleepless night. Healthy participants were asked to breathe as long as possible until task failure against a moderate inspiratory threshold constraint. Transdiaphragmatic pressure and diaphragm electrical activity were measured throughout the trial to assess pressure output of the diaphragm and overall respiratory motor output. Cortical contribution to respiratory motor output was assessed by measurement of preinspiratory motor potential amplitude and by cervical magnetic simulation. Twenty healthy male participants were studied. Time to task failure was significantly shorter after sleep deprivation than after normal sleep: (30 min [interquartile range [IQR], 17-41] vs. 60 min [IQR, 45-60],  = 0.002). At the beginning of the trial, preinspiratory motor potential amplitude was significantly lower in the sleep-deprivation condition (4.5 μV [IQR, 2.5-6.4] vs. 7.3 μV [IQR, 4.3-10.4],  = 0.02) and correlated significantly with the duration of the endurance trial. In the sleep-deprivation condition, preinspiratory motor potential amplitude, electrical activity of the diaphragm, pressure output of the diaphragm, and Vt decreased and the respiratory rate increased significantly from the beginning to the end of the trial. Such decreases did not occur in the normal-sleep condition. One night of sleep deprivation reduces respiratory motor output by altering its cortical component with subsequent reduction of inspiratory endurance by half. These results suggest that altered sleep triggers severe brain dysfunctions that could precipitate respiratory failure.
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http://dx.doi.org/10.1164/rccm.201904-0819OCDOI Listing
April 2020

Immersive simulation training at 6-week intervals for 1 year and multidisciplinary team performance scores: a randomized controlled trial of simulation training for life-threatening pediatric emergencies.

Emergencias 2019 Dic;31(6):391-398

ABS Lab, Simulation Center, Faculty of Medicine, University of Poitiers, Francia. Pediatric Emergency Department, University Hospital of Poitiers, Francia.

Objectives: To demonstrate an effect of 1 year of training using immersive simulations repeated every 6 weeks versus every 6 months to improve the performance of multidisciplinary teams (MDTs) working with children in lifethreatening situations.

Material And Methods: Randomized controlled trial in 12 MDTs of emergency responders in France. Each MDT consisted of 4 persons: a physician, a resident, a nurse, and the ambulance driver. Six MDTs participated in 9 different high-fidelity simulations of pediatric shock over the course of a year. Six control MDTs were presented with 3 of the experimental group's simulations at 3 time points (starting point, 6 months, and 1 year). Technical performance was assessed with the Team Average Performance Assessment Scale (TAPAS) and an intraosseous (IO) access performance scale. Nontechnical performance assessment instruments were the Clinical Teamwork Scale (CTS) and, for leadership, the Behavioral Assessment Tool (BAT). Progress over time was analyzed by comparing the 2 groups during the 3 simulations they experienced in common.

Results: Performance scores rose significantly over the study period in the experimental group (P=.01 for the TAPAS score, P=.008 for IO access, P=.03 for the CTS score, and P=.02 for the BAT score) but did not change in the control group (P=.46 for TAPAS, P=.55 for IO access, P=.62 for CTS, and P=.58 for BAT). All mean (SD) scores were higher in the experimental group than in the control group in the last session: TAPAS, 55.8 ± 6.3 vs 31.2 ± 10.3, P=.01; IO access, 91.7 ± 8.0 vs 62.9 ± 16.2, P=.01; CTS, 63.2 ± 9.3 vs 47.2 ± 13.1, P=.03; and BAT, 72.8 ± 5.1 vs 51.2 ± 14.3, P=.01). The 6-month assessment showed significant between-group differences on 2 technical performance measures (P=.02 for TAPAS and P=.03 for IO access); the experimental group's scores were higher. We also observed close correlations between the performance of the leader and the group on both nontechnical (rho > 0.9) and technical (rho > 0.7) assessments.

Conclusion: Simulation-based training should be repeated more than 3 times per year. Our findings suggest the advisability of repeating simulations of infrequent, high-risk scenarios every 6 weeks to improve all performance scores and guarantee acceptable technical and nontechnical performance throughout the year.
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September 2020

Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial.

JAMA 2019 10;322(15):1465-1475

Centre Hospitalier Emile Roux, Service de Réanimation, Le Puy en Velay, France.

Importance: High-flow nasal oxygen may prevent postextubation respiratory failure in the intensive care unit (ICU). The combination of high-flow nasal oxygen with noninvasive ventilation (NIV) may be an optimal strategy of ventilation to avoid reintubation.

Objective: To determine whether high-flow nasal oxygen with prophylactic NIV applied immediately after extubation could reduce the rate of reintubation, compared with high-flow nasal oxygen alone, in patients at high risk of extubation failure in the ICU.

Design, Setting, And Participants: Multicenter randomized clinical trial conducted from April 2017 to January 2018 among 641 patients at high risk of extubation failure (ie, older than 65 years or with an underlying cardiac or respiratory disease) at 30 ICUs in France; follow-up was until April 2018.

Interventions: Patients were randomly assigned to high-flow nasal oxygen alone (n = 306) or high-flow nasal oxygen alternating with NIV (n = 342) immediately after extubation.

Main Outcomes And Measures: The primary outcome was the proportion of patients reintubated at day 7; secondary outcomes included postextubation respiratory failure at day 7, reintubation rates up until ICU discharge, and ICU mortality.

Results: Among 648 patients who were randomized (mean [SD] age, 70 [10] years; 219 women [34%]), 641 patients completed the trial. The reintubation rate at day 7 was 11.8% (95% CI, 8.4%-15.2%) (40/339) with high-flow nasal oxygen and NIV and 18.2% (95% CI, 13.9%-22.6%) (55/302) with high-flow nasal oxygen alone (difference, -6.4% [95% CI, -12.0% to -0.9%]; P = .02). Among the 11 prespecified secondary outcomes, 6 showed no significant difference. The proportion of patients with postextubation respiratory failure at day 7 (21% vs 29%; difference, -8.7% [95% CI, -15.2% to -1.8%]; P = .01) and reintubation rates up until ICU discharge (12% vs 20%, difference -7.4% [95% CI, -13.2% to -1.8%]; P = .009) were significantly lower with high-flow nasal oxygen and NIV than with high-flow nasal oxygen alone. ICU mortality rates were not significantly different: 6% with high-flow nasal oxygen and NIV and 9% with high-flow nasal oxygen alone (difference, -2.4% [95% CI, -6.7% to 1.7%]; P = .25).

Conclusions And Relevance: In mechanically ventilated patients at high risk of extubation failure, the use of high-flow nasal oxygen with NIV immediately after extubation significantly decreased the risk of reintubation compared with high-flow nasal oxygen alone.

Trial Registration: ClinicalTrials.gov Identifier: NCT03121482.
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http://dx.doi.org/10.1001/jama.2019.14901DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802261PMC
October 2019

Balloon catheter vs oxytocin alone for induction of labor in women with a previous cesarean section: A randomized controlled trial.

Acta Obstet Gynecol Scand 2020 02 6;99(2):259-266. Epub 2019 Sep 6.

Department of Obstetrics and Gynecology, University Hospital of Poitiers, Poitiers, France.

Introduction: The aim of this study was to compare the efficacy and maternal-neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavorable cervix.

Material And Methods: This open-label randomized controlled trial took place in seven French hospitals. Inclusion criteria were medical indication for labor induction in pregnant women, ≥37 weeks, with lower segment cesarean section, Bishop score ≤4, no pre-labor rupture of membranes, singleton fetus in cephalic presentation. Women were allocated randomly to induction with a 50-mL balloon catheter for 12 hours or a low-dose oxytocin infusion. Primary outcome was the rate of vaginal birth. Secondary outcomes were maternal and neonatal complications.

Results: The study enrolled 204 women from 26 December 2010 to 31 December 2013: 101 were allocated to receive balloon catheter and 103 to oxytocin. Vaginal birth rate was 50% (n = 51) in the balloon catheter group vs 37% (n = 38) in the oxytocin group (P = 0.050). Maternal and neonatal morbidity did not differ between balloon catheter and oxytocin groups: two uterine dehiscences vs one, one vs four maternal infections, five vs two hemorrhages and 11 vs five neonatal transfers, respectively. Heterogeneity of treatment effect for vaginal delivery was observed across initial Bishop scores. Balloon catheter was more effective for low values of bishop score.

Conclusions: Balloon catheter tended to be associated with a higher probability of vaginal delivery as compared with low-dose intravenous oxytocin when used for induction of labor in women with a previous cesarean section and low Bishop score at induction.
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http://dx.doi.org/10.1111/aogs.13712DOI Listing
February 2020

High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol.

BMJ Open 2019 08 10;9(8):e029798. Epub 2019 Aug 10.

Medical ICU, CHU d'Angers, Angers, France.

Introduction: Non-invasive ventilation (NIV) is recommended as first-line therapy in respiratory failure of critically ill immunocompromised patients as it can decrease intubation and mortality rates as compared with standard oxygen. However, its recommendation is only conditional. Indeed, the use of NIV in this setting has been challenged recently based on results of trials finding similar outcomes with or without NIV or even deleterious effects of NIV. To date, NIV has been compared with standard oxygen but not to high-flow nasal oxygen therapy (HFOT) in immunocompromised patients. Several studies have found lower mortality rates using HFOT alone than when using HFOT with NIV sessions in patients with de novo respiratory failure, and even in immunocompromised patients. We are hypothesising that HFOT alone is more effective than HFOT with NIV sessions and reduces mortality of immunocompromised patients with acute hypoxemic respiratory failure.

Methods And Analysis: This study is an investigator-initiated, multicentre randomised controlled trial comparing HFOT alone or with NIV in immunocompromised patients admitted to intensive care unit (ICU) for severe acute hypoxemic respiratory failure. Around 280 patients will be randomised with a 1:1 ratio in two groups. The primary outcome is the mortality rate at day 28 after inclusion. Secondary outcomes include the rate of intubation in each group, length of ICU and hospital stay and mortality up to day 180.

Ethics And Dissemination: The study has been approved by the ethics committee and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial Registration Number: NCT02978300.
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http://dx.doi.org/10.1136/bmjopen-2019-029798DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6701687PMC
August 2019

H- P magnetic resonance spectroscopy: effect of biotin in multiple sclerosis.

Ann Clin Transl Neurol 2019 07 27;6(7):1332-1337. Epub 2019 Jun 27.

DACTIM-MIS Team - LMA CNRS 7348, Poitiers University Medical Center, Poitiers Cedex, France.

Biotin is thought to improve functional impairment in progressive multiple sclerosis (MS) by upregulating bioenergetic metabolism. We enrolled 19 patients suffering from progressive MS (5 primary and 14 secondary Progressive-MS). Using cerebral multinuclear magnetic resonance spectroscopy (MMRS) and clinical evaluation before and after 6 months of biotin cure, we showed significant modifications of: PME/PDE, ATP, and lactate resonances; an improvement of EDSS Neuroscore. Our results are consistent with metabolic pathways concerned with biotin action and could suggest the usefulness of MMRS for monitoring.
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http://dx.doi.org/10.1002/acn3.50825DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6649368PMC
July 2019

Stress response in the daily lives of simulation repeaters. A randomized controlled trial assessing stress evolution over one year of repetitive immersive simulations.

PLoS One 2019 25;14(7):e0220111. Epub 2019 Jul 25.

ABS Lab, Simulation Center, Faculty of Medicine, University of Poitiers, Poitiers, France.

Background: Simulations in healthcare reproduce clinical situations in stressful conditions. Repeated stress exposure might influence the learning process in simulation as well as real-life.

Objectives: 1) To record heart rate and heart rate variability evolution during one-day simulation over one year; 2) To analyze the effect of repetitive high-fidelity simulations on the risk of post-traumatic stress disorder.

Study Design: Single-center, investigator-initiated RCT. 48 participants were randomized in 12 multidisciplinary teams of French Emergency Medical Services to manage infant shock in high-fidelity simulations. In the experimental group, 6 multidisciplinary teams were exposed to 9 different simulation sessions over 1 year. In the control group, 6 multidisciplinary teams participated in only 3 simulation sessions, in common with those of the experimental group (initial, intermediate after 6 months, and finally after 1 year). Heart rate (HR) and heart rate variability (HRV) were analyzed on a 24-hour Holter from the day prior to simulation until the end of simulation. Questionnaires of Impact of Event Scale-Revised at 7 days and Post-traumatic Check-List Scale at 1 month were used to detect possible post-traumatic stress disorder in participants. p<0.05 was considered significant.

Results: Stress increased during each simulation in the two groups. After analysis on the 24-hour period, there was no significant difference between the two groups during the initial simulation session in terms of heart rate and heart rate variability. In the 24-hour period of the intermediate and final simulation sessions, the level of stress was higher in the control group during the diurnal (p = 0.04) and nocturnal periods (p = 0.01). No participant developed post-traumatic stress disorder after the 72 simulation sessions.

Conclusions: Despite the stress generated by simulation, the more the sessions were repeated, the less were their repercussions on the daily lives of participants, reflected by a lower sympathetic activity. Moreover, repetition of simulations did not lead to post-traumatic stress disorder.

Trial Registration: ClinicalTrials.gov NCT02424890.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0220111PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6657860PMC
March 2020

No association between fear of hypoglycemia and blood glucose variability in type 1 diabetes: The cross-sectional VARDIA study.

J Diabetes Complications 2019 08 10;33(8):554-560. Epub 2019 May 10.

L'institut du thorax, INSERM, CNRS, UNIV Nantes, CHU Nantes, Nantes, France.

Aims: In type 1 diabetes (T1D), treatment efficacy is limited by the unpredictability of blood glucose results and glycemic variability (GV). Fear of Hypoglycemia (FOH) remains a major brake for insulin treatment optimization. We aimed to assess the association of GV with FOH in participants with T1D in an observational cross-sectional study performed in 9 French Diabetes Centres (NCT02790060).

Methods: Participants were T1D for ≥5 years, aged 18-75 years, on stable insulin therapy for ≥3 months. The coefficient of variation (CV) of blood glucose and mean amplitude of glycemic excursions (MAGE) were used to assess GV from 7-point self-monitoring of blood glucose (SMBG). FOH was assessed using the validated French version of the Hypoglycemia Fear Survey-II (HFS-II) questionnaire.

Results: Among a total of 570 recruited participants, 298 were suitable for analysis: 46% women, 58% on continuous subcutaneous insulin infusion [CSII], mean age 49 ± 16 years, HbA1c 7.5 ± 0.9%, HFS-II score 67 ± 18 and 12% with recent history of severe hypoglycemia during the previous 6 months, mean CV 39.8 ± 9.7% and MAGE 119 ± 42 mg/dL. CV and MAGE did not significantly correlate with HFS-II score (R = -0.05;P = 0.457 and R = 0.08;P = 0.170). Participants with severe hypoglycemia in the previous 6 months had higher HFS scores. Participants with higher HFS scores presented more hypoglycemias during follow-up.

Conclusions: FOH as determined using the HFS-II questionnaire was not associated with 7-point SMBG variability in participants with T1D, but was associated with a positive history of severe hypoglycemia. Higher FOH was associated with higher frequency of hypoglycemia during follow-up.
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http://dx.doi.org/10.1016/j.jdiacomp.2019.05.003DOI Listing
August 2019
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