Publications by authors named "Carlos Ferrando"

59 Publications

Rationale and study design of an early care, therapeutic education, and psychological intervention program for the management of post-intensive care syndrome and chronic pain after COVID-19 infection (PAIN-COVID): study protocol for a randomized controlled trial.

Trials 2021 Jul 24;22(1):486. Epub 2021 Jul 24.

Pain Medicine Section, Department of Anaesthesiology, Critical Care and Pain Treatment, Hospital Clínic de Barcelona, Barcelona, Spain.

Background: Critically ill patients with COVID-19 are an especially susceptible population to develop post-intensive care syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe pain and may have long-term mental, cognitive, and functional health deterioration after discharge. However, few controlled trials are evaluating interventions for the prevention and treatment of PICS. The study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19. The primary objective is to determine whether the program is superior to standard-of-care on health-related quality of life at 6 months after hospital discharge. The secondary objectives are to determine whether the intervention is superior to standard-of-care on health-related quality of life, incidence of chronic pain and degree of functional limitation, incidence of anxiety, depression, and post-traumatic stress syndrome at 3 and 6 months after hospital discharge.

Methods: The PAINCOVID trial is a unicentric randomized, controlled, patient-blinded superiority trial with two parallel groups. The primary endpoint is the health-related quality of life at 6 months after hospital discharge, and randomization will be performed with a 1:1 allocation ratio. This paper details the methodology and statistical analysis plan of the trial and was submitted before outcome data were available. The estimated sample size is 84 patients, 42 for each arm. Assuming a lost to follow-up rate of 20%, a sample size of 102 patients is necessary (51 for each arm).

Discussion: This is the first randomized clinical trial assessing the effectiveness of an early care therapeutic education, and psychological intervention program for the management of PICS and chronic pain after COVID-19. The intervention will serve as proof of the need to implement early care programs at an early stage, having an incalculable impact given the current scenario of the pandemic.

Trial Registration: This study is being conducted in accordance with the tenets of the Helsinki Declaration and has been approved by the authors' institutional review board Comité Ético de Investigación Clínica del Hospital Clínic de Barcelona (approval number: HCB/2020/0549) and was registered on May 9, 2020, at clinicaltrials.gov ( NCT04394169 ).
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http://dx.doi.org/10.1186/s13063-021-05463-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8310406PMC
July 2021

Stratification for Identification of Prognostic Categories In the Acute RESpiratory Distress Syndrome (SPIRES) Score.

Crit Care Med 2021 Jul 2. Epub 2021 Jul 2.

1 CIBER de Enfermedades Respiratorias, Instituto Salud Carlos III, Madrid, Spain. 2 Research Unit, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain. 3 Division of Biostatistics, Research Unit, Hospital Universitario Dr. Negrín, Las Palmas, Spain. 4 Intensive Care Unit, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain. 5 Intensive Care Unit, Hospital Universitario A Coruña, La Coruña, Spain. 6 Intensive Care Unit, Hospital Universitario Virgen de Arrixaca, Murcia, Spain. 7 Intensive Care Unit, Hospital Universitario Río Hortega, Valladolid, Spain. 8 Intensive Care Unit, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. 9 Intensive Care Unit, Hospital Virgen de la Luz, Cuenca, Spain. 10 Department of Anesthesiology, Hospital Clínico Universitario de Valencia, Valencia, Spain. 11 Intensive Care Unit, Complejo Asistencial Universitario de León, León, Spain. 12 Intensive Care Unit, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain. 13 Intensive Care Unit, Hospital Universitario NS de Candelaria, Santa Cruz de Tenerife, Spain. 14 Intensive Care Unit, Fundación Hospital Universitario Jiménez Díaz, Madrid, Spain. 15 Department of Anesthesiology and Critical Care, Hospital Clinic, Institut D'investigació August Pi i Sunyer, Barcelona, Spain. 16 Intensive Care Unit, Hospital Regional Universitario de Málaga Carlos Haya, Málaga, Spain. 17 Intensive Care Unit, Hospital Universitario Mutua Terrassa, Terrassa, Barcelona, Spain. 18 Department of Thoracic Surgery, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain. 19 Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands. 20 Department of Public Health, Erasmus MC, Rotterdam, The Netherlands. 21 Department of Respiratory Care, Massachusetts General Hospital, Boston, MA. 22 Department of Anesthesiology, Harvard University, Boston, MA.

Objectives: To develop a scoring model for stratifying patients with acute respiratory distress syndrome into risk categories (Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score) for early prediction of death in the ICU, independent of the underlying disease and cause of death.

Design: A development and validation study using clinical data from four prospective, multicenter, observational cohorts.

Setting: A network of multidisciplinary ICUs.

Patients: One-thousand three-hundred one patients with moderate-to-severe acute respiratory distress syndrome managed with lung-protective ventilation.

Interventions: None.

Measurements And Main Results: The study followed Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis guidelines for prediction models. We performed logistic regression analysis, bootstrapping, and internal-external validation of prediction models with variables collected within 24 hours of acute respiratory distress syndrome diagnosis in 1,000 patients for model development. Primary outcome was ICU death. The Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score was based on patient's age, number of extrapulmonary organ failures, values of end-inspiratory plateau pressure, and ratio of PaO2 to FIO2 assessed at 24 hours of acute respiratory distress syndrome diagnosis. The pooled area under the receiver operating characteristic curve across internal-external validations was 0.860 (95% CI, 0.831-0.890). External validation in a new cohort of 301 acute respiratory distress syndrome patients confirmed the accuracy and robustness of the scoring model (area under the receiver operating characteristic curve = 0.870; 95% CI, 0.829-0.911). The Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score stratified patients in three distinct prognostic classes and achieved better prediction of ICU death than ratio of PaO2 to FIO2 at acute respiratory distress syndrome onset or at 24 hours, Acute Physiology and Chronic Health Evaluation II score, or Sequential Organ Failure Assessment scale.

Conclusions: The Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score represents a novel strategy for early stratification of acute respiratory distress syndrome patients into prognostic categories and for selecting patients for therapeutic trials.
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http://dx.doi.org/10.1097/CCM.0000000000005142DOI Listing
July 2021

Predictors of failure with high-flow nasal oxygen therapy in COVID-19 patients with acute respiratory failure: a multicenter observational study.

J Intensive Care 2021 Mar 5;9(1):23. Epub 2021 Mar 5.

Department of Anesthesiology and Critical Care, Hospital Clínic, Institut D'investigació August Pi i Sunyer, Villarroel 170, 08025, Barcelona, Spain.

Purpose: We aimed to describe the use of high-flow nasal oxygen (HFNO) in patients with COVID-19 acute respiratory failure and factors associated with a shift to invasive mechanical ventilation.

Methods: This is a multicenter, observational study from a prospectively collected database of consecutive COVID-19 patients admitted to 36 Spanish and Andorran intensive care units (ICUs) who received HFNO on ICU admission during a 22-week period (March 12-August 13, 2020). Outcomes of interest were factors on the day of ICU admission associated with the need for endotracheal intubation. We used multivariable logistic regression and mixed effects models. A predictive model for endotracheal intubation in patients treated with HFNO was derived and internally validated.

Results: From a total of 259 patients initially treated with HFNO, 140 patients (54%) required invasive mechanical ventilation. Baseline non-respiratory Sequential Organ Failure Assessment (SOFA) score [odds ratio (OR) 1.78; 95% confidence interval (CI) 1.41-2.35], and the ROX index calculated as the ratio of partial pressure of arterial oxygen to inspired oxygen fraction divided by respiratory rate (OR 0.53; 95% CI: 0.37-0.72), and pH (OR 0.47; 95% CI: 0.24-0.86) were associated with intubation. Hospital site explained 1% of the variability in the likelihood of intubation after initial treatment with HFNO. A predictive model including non-respiratory SOFA score and the ROX index showed excellent performance (AUC 0.88, 95% CI 0.80-0.96).

Conclusions: Among adult critically ill patients with COVID-19 initially treated with HFNO, the SOFA score and the ROX index may help to identify patients with higher likelihood of intubation.
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http://dx.doi.org/10.1186/s40560-021-00538-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7934982PMC
March 2021

High-flow nasal oxygen in patients with COVID-19-associated acute respiratory failure.

Crit Care 2021 02 11;25(1):58. Epub 2021 Feb 11.

Department of Anesthesiology and Critical Care, Institut D'investigació August Pi I Sunyer, Hospital Clínic, Villarroel 170, 08025, Barcelona, Spain.

Purpose: Whether the use of high-flow nasal oxygen in adult patients with COVID-19 associated acute respiratory failure improves clinically relevant outcomes remains unclear. We thus sought to assess the effect of high-flow nasal oxygen on ventilator-free days, compared to early initiation of invasive mechanical ventilation, on adult patients with COVID-19.

Methods: We conducted a multicentre cohort study using a prospectively collected database of patients with COVID-19 associated acute respiratory failure admitted to 36 Spanish and Andorran intensive care units (ICUs). Main exposure was the use of high-flow nasal oxygen (conservative group), while early invasive mechanical ventilation (within the first day of ICU admission; early intubation group) served as the comparator. The primary outcome was ventilator-free days at 28 days. ICU length of stay and all-cause in-hospital mortality served as secondary outcomes. We used propensity score matching to adjust for measured confounding.

Results: Out of 468 eligible patients, a total of 122 matched patients were included in the present analysis (61 for each group). When compared to early intubation, the use of high-flow nasal oxygen was associated with an increase in ventilator-free days (mean difference: 8.0 days; 95% confidence interval (CI): 4.4 to 11.7 days) and a reduction in ICU length of stay (mean difference: - 8.2 days; 95% CI - 12.7 to - 3.6 days). No difference was observed in all-cause in-hospital mortality between groups (odds ratio: 0.64; 95% CI: 0.25 to 1.64).

Conclusions: The use of high-flow nasal oxygen upon ICU admission in adult patients with COVID-19 related acute hypoxemic respiratory failure may lead to an increase in ventilator-free days and a reduction in ICU length of stay, when compared to early initiation of invasive mechanical ventilation. Future studies should confirm our findings.
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http://dx.doi.org/10.1186/s13054-021-03469-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7876530PMC
February 2021

Early corticosteroids are associated with lower mortality in critically ill patients with COVID-19: a cohort study.

Crit Care 2021 01 4;25(1). Epub 2021 Jan 4.

CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.

Background: Critically ill patients with coronavirus disease 19 (COVID-19) have a high fatality rate likely due to a dysregulated immune response. Corticosteroids could attenuate this inappropriate response, although there are still some concerns regarding its use, timing, and dose.

Methods: This is a nationwide, prospective, multicenter, observational, cohort study in critically ill adult patients with COVID-19 admitted into Intensive Care Units (ICU) in Spain from 12th March to 29th June 2020. Using a multivariable Cox model with inverse probability weighting, we compared relevant outcomes between patients treated with early corticosteroids (before or within the first 48 h of ICU admission) with those who did not receive early corticosteroids (delayed group) or any corticosteroids at all (never group). Primary endpoint was ICU mortality. Secondary endpoints included 7-day mortality, ventilator-free days, and complications.

Results: A total of 691 patients out of 882 (78.3%) received corticosteroid during their hospital stay. Patients treated with early-corticosteroids (n = 485) had lower ICU mortality (30.3% vs. never 36.6% and delayed 44.2%) and lower 7-day mortality (7.2% vs. never 15.2%) compared to non-early treated patients. They also had higher number of ventilator-free days, less length of ICU stay, and less secondary infections than delayed treated patients. There were no differences in medical complications between groups. Of note, early use of moderate-to-high doses was associated with better outcomes than low dose regimens.

Conclusion: Early use of corticosteroids in critically ill patients with COVID-19 is associated with lower mortality than no or delayed use, and fewer complications than delayed use.
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http://dx.doi.org/10.1186/s13054-020-03422-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7780210PMC
January 2021

Characteristics and Outcomes in Patients with Ventilator-Associated Pneumonia Who Do or Do Not Develop Acute Respiratory Distress Syndrome. An Observational Study.

J Clin Med 2020 Oct 29;9(11). Epub 2020 Oct 29.

Department of Pneumology and Respiratory Intensive Care Unit, Institut Clinic de Respiratori, Hospital Clinic of Barcelona, 08036 Barcelona, Spain.

Ventilator-associated pneumonia (VAP) is a well-known complication of patients on invasive mechanical ventilation. The main cause of acute respiratory distress syndrome (ARDS) is pneumonia. ARDS can occur in patients with community-acquired or nosocomial pneumonia. Data regarding ARDS incidence, related pathogens, and specific outcomes in patients with VAP is limited. This is a cohort study in which patients with VAP were evaluated in an 800-bed tertiary teaching hospital between 2004 and 2016. Clinical outcomes, microbiological and epidemiological data were assessed among those who developed ARDS and those who did not. Forty-one (13.6%) out of 301 VAP patients developed ARDS. Patients who developed ARDS were younger and presented with higher prevalence of chronic liver disease. Pseudomonas aeruginosa was the most frequently isolated pathogen, but without any difference between groups. Appropriate empirical antibiotic treatment was prescribed to ARDS patients as frequently as to those without ARDS. Ninety-day mortality did not significantly vary among patients with or without ARDS. Additionally, patients with ARDS did not have significantly higher intensive care unit (ICU) and 28-day mortality, ICU, and hospital length of stay, ventilation-free days, and duration of mechanical ventilation. In summary, ARDS deriving from VAP occurs in 13.6% of patients. Although significant differences in clinical outcomes were not observed between both groups, further studies with a higher number of patients are needed due to the possibility of the study being underpowered.
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http://dx.doi.org/10.3390/jcm9113508DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7692126PMC
October 2020

Awake prone positioning does not reduce the risk of intubation in COVID-19 treated with high-flow nasal oxygen therapy: a multicenter, adjusted cohort study.

Crit Care 2020 10 6;24(1):597. Epub 2020 Oct 6.

CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.

Background: Awake prone positioning (awake-PP) in non-intubated coronavirus disease 2019 (COVID-19) patients could avoid endotracheal intubation, reduce the use of critical care resources, and improve survival. We aimed to examine whether the combination of high-flow nasal oxygen therapy (HFNO) with awake-PP prevents the need for intubation when compared to HFNO alone.

Methods: Prospective, multicenter, adjusted observational cohort study in consecutive COVID-19 patients with acute respiratory failure (ARF) receiving respiratory support with HFNO from 12 March to 9 June 2020. Patients were classified as HFNO with or without awake-PP. Logistic models were fitted to predict treatment at baseline using the following variables: age, sex, obesity, non-respiratory Sequential Organ Failure Assessment score, APACHE-II, C-reactive protein, days from symptoms onset to HFNO initiation, respiratory rate, and peripheral oxyhemoglobin saturation. We compared data on demographics, vital signs, laboratory markers, need for invasive mechanical ventilation, days to intubation, ICU length of stay, and ICU mortality between HFNO patients with and without awake-PP.

Results: A total of 1076 patients with COVID-19 ARF were admitted, of which 199 patients received HFNO and were analyzed. Fifty-five (27.6%) were pronated during HFNO; 60 (41%) and 22 (40%) patients from the HFNO and HFNO + awake-PP groups were intubated. The use of awake-PP as an adjunctive therapy to HFNO did not reduce the risk of intubation [RR 0.87 (95% CI 0.53-1.43), p = 0.60]. Patients treated with HFNO + awake-PP showed a trend for delay in intubation compared to HFNO alone [median 1 (interquartile range, IQR 1.0-2.5) vs 2 IQR 1.0-3.0] days (p = 0.055), but awake-PP did not affect 28-day mortality [RR 1.04 (95% CI 0.40-2.72), p = 0.92].

Conclusion: In patients with COVID-19 ARF treated with HFNO, the use of awake-PP did not reduce the need for intubation or affect mortality.
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http://dx.doi.org/10.1186/s13054-020-03314-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7537953PMC
October 2020

Neurally adjusted ventilatory assist in acute respiratory failure: a randomized controlled trial.

Intensive Care Med 2020 12 6;46(12):2327-2337. Epub 2020 Sep 6.

CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.

Purpose: We hypothesized that neurally adjusted ventilatory assist (NAVA) compared to conventional lung-protective mechanical ventilation (MV) decreases duration of MV and mortality in patients with acute respiratory failure (ARF).

Methods: We carried out a multicenter, randomized, controlled trial in patients with ARF from several etiologies. Intubated patients ventilated for ≤ 5 days expected to require MV for ≥ 72 h and able to breathe spontaneously were eligible for enrollment. Eligible patients were randomly assigned based on balanced treatment assignments with a computerized randomization allocation sequence to two ventilatory strategies: (1) lung-protective MV (control group), and (2) lung-protective MV with NAVA (NAVA group). Allocation concealment was maintained at all sites during the trial. Primary outcome was the number of ventilator-free days (VFDs) at 28 days. Secondary outcome was all-cause hospital mortality. All analyses were done according to the intention-to-treat principle.

Results: Between March 2014 and October 2019, we enrolled 306 patients and randomly assigned 153 patients to the NAVA group and 153 to the control group. Median VFDs were higher in the NAVA than in the control group (22 vs. 18 days; between-group difference 4 days; 95% confidence interval [CI] 0 to 8 days; p = 0.016). At hospital discharge, 39 (25.5%) patients in the NAVA group and 47 (30.7%) patients in the control group had died (between-group difference - 5.2%, 95% CI - 15.2 to 4.8, p = 0.31). Other clinical, physiological or safety outcomes did not differ significantly between the trial groups.

Conclusion: NAVA decreased duration of MV although it did not improve survival in ventilated patients with ARF.
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http://dx.doi.org/10.1007/s00134-020-06181-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7474954PMC
December 2020

Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19: study protocol for a randomized controlled superiority trial.

Trials 2020 Aug 16;21(1):717. Epub 2020 Aug 16.

Keenan Research Center for Biomedical Science at the Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Canada.

Background: There are no specific generally accepted therapies for the coronavirus disease 2019 (COVID-19). The full spectrum of COVID-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multisystem organ failure, and death. The efficacy of corticosteroids in viral ARDS remains unknown. We postulated that adjunctive treatment of established ARDS caused by COVID-19 with intravenous dexamethasone might change the pulmonary and systemic inflammatory response and thereby reduce morbidity, leading to a decrease in duration of mechanical ventilation and in mortality.

Methods/design: This is a multicenter, randomized, controlled, parallel, open-label, superiority trial testing dexamethasone in 200 mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed SARS-CoV-2 infection. Established ARDS is defined as maintaining a PaO/FiO ≤ 200 mmHg on PEEP ≥ 10 cmHO and FiO ≥ 0.5 after 12 ± 3 h of routine intensive care. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after randomization. All analyses will be done according to the intention-to-treat principle.

Discussion: This study will assess the role of dexamethasone in patients with established moderate-to-severe ARDS caused by SARS-CoV-2.

Trial Registration: ClinicalTrials.gov NCT04325061 . Registered on 25 March 2020 as DEXA-COVID19.
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http://dx.doi.org/10.1186/s13063-020-04643-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7429135PMC
August 2020

Clinical features, ventilatory management, and outcome of ARDS caused by COVID-19 are similar to other causes of ARDS.

Intensive Care Med 2020 12 29;46(12):2200-2211. Epub 2020 Jul 29.

CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.

Purpose: The main characteristics of mechanically ventilated ARDS patients affected with COVID-19, and the adherence to lung-protective ventilation strategies are not well known. We describe characteristics and outcomes of confirmed ARDS in COVID-19 patients managed with invasive mechanical ventilation (MV).

Methods: This is a multicenter, prospective, observational study in consecutive, mechanically ventilated patients with ARDS (as defined by the Berlin criteria) affected with with COVID-19 (confirmed SARS-CoV-2 infection in nasal or pharyngeal swab specimens), admitted to a network of 36 Spanish and Andorran intensive care units (ICUs) between March 12 and June 1, 2020. We examined the clinical features, ventilatory management, and clinical outcomes of COVID-19 ARDS patients, and compared some results with other relevant studies in non-COVID-19 ARDS patients.

Results: A total of 742 patients were analysed with complete 28-day outcome data: 128 (17.1%) with mild, 331 (44.6%) with moderate, and 283 (38.1%) with severe ARDS. At baseline, defined as the first day on invasive MV, median (IQR) values were: tidal volume 6.9 (6.3-7.8) ml/kg predicted body weight, positive end-expiratory pressure 12 (11-14) cmHO. Values of respiratory system compliance 35 (27-45) ml/cmHO, plateau pressure 25 (22-29) cmHO, and driving pressure 12 (10-16) cmHO were similar to values from non-COVID-19 ARDS patients observed in other studies. Recruitment maneuvers, prone position and neuromuscular blocking agents were used in 79%, 76% and 72% of patients, respectively. The risk of 28-day mortality was lower in mild ARDS [hazard ratio (RR) 0.56 (95% CI 0.33-0.93), p = 0.026] and moderate ARDS [hazard ratio (RR) 0.69 (95% CI 0.47-0.97), p = 0.035] when compared to severe ARDS. The 28-day mortality was similar to other observational studies in non-COVID-19 ARDS patients.

Conclusions: In this large series, COVID-19 ARDS patients have features similar to other causes of ARDS, compliance with lung-protective ventilation was high, and the risk of 28-day mortality increased with the degree of ARDS severity.
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http://dx.doi.org/10.1007/s00134-020-06192-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7387884PMC
December 2020

Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial.

Lancet Respir Med 2020 03 7;8(3):267-276. Epub 2020 Feb 7.

Biostatistics Research Unit, Hospital Universitario Dr Negrín, Las Palmas de Gran Canaria, Spain.

Background: There is no proven specific pharmacological treatment for patients with the acute respiratory distress syndrome (ARDS). The efficacy of corticosteroids in ARDS remains controversial. We aimed to assess the effects of dexamethasone in ARDS, which might change pulmonary and systemic inflammation and result in a decrease in duration of mechanical ventilation and mortality.

Methods: We did a multicentre, randomised controlled trial in a network of 17 intensive care units (ICUs) in teaching hospitals across Spain in patients with established moderate-to-severe ARDS (defined by a ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen of 200 mm Hg or less assessed with a positive end-expiratory pressure of 10 cm HO or more and FiO of 0·5 or more at 24 h after ARDS onset). Patients with brain death, terminal-stage disease, or receiving corticosteroids or immunosuppressive drugs were excluded. Eligible patients were randomly assigned based on balanced treatment assignments with a computerised randomisation allocation sequence using blocks of 10 opaque, sealed envelopes to receive immediate treatment with dexamethasone or continued routine intensive care (control group). Patients in the dexamethasone group received an intravenous dose of 20 mg once daily from day 1 to day 5, which was reduced to 10 mg once daily from day 6 to day 10. Patients in both groups were ventilated with lung-protective mechanical ventilation. Allocation concealment was maintained at all sites during the trial. Primary outcome was the number of ventilator-free days at 28 days, defined as the number of days alive and free from mechanical ventilation from day of randomisation to day 28. Secondary outcome was all-cause mortality 60 days after randomisation. All analyses were done according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, NCT01731795.

Findings: Between March 28, 2013, and Dec 31, 2018, we enrolled 277 patients and randomly assigned 139 patients to the dexamethasone group and 138 to the control group. The trial was stopped by the data safety monitoring board due to low enrolment rate after enrolling more than 88% (277/314) of the planned sample size. The mean number of ventilator-free days was higher in the dexamethasone group than in the control group (between-group difference 4·8 days [95% CI 2·57 to 7·03]; p<0·0001). At 60 days, 29 (21%) patients in the dexamethasone group and 50 (36%) patients in the control group had died (between-group difference -15·3% [-25·9 to -4·9]; p=0·0047). The proportion of adverse events did not differ significantly between the dexamethasone group and control group. The most common adverse events were hyperglycaemia in the ICU (105 [76%] patients in the dexamethasone group vs 97 [70%] patients in the control group), new infections in the ICU (eg, pneumonia or sepsis; 33 [24%] vs 35 [25%]), and barotrauma (14 [10%] vs 10 [7%]).

Interpretation: Early administration of dexamethasone could reduce duration of mechanical ventilation and overall mortality in patients with established moderate-to-severe ARDS.

Funding: Fundación Mutua Madrileña, Instituto de Salud Carlos III, The European Regional Development's Funds, Asociación Científica Pulmón y Ventilación Mecánica.
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http://dx.doi.org/10.1016/S2213-2600(19)30417-5DOI Listing
March 2020

Spontaneous recovery of neuromuscular blockade is an independent risk factor for postoperative pulmonary complications after abdominal surgery: A secondary analysis.

Eur J Anaesthesiol 2020 Mar;37(3):203-211

From the Department of Anaesthesiology, Hospital General Universitario Gregorio Marañón, Madrid (IG), Department of Anaesthesiology, Consorcio Hospital General Universitario de Valencia (CLE), Department of Anaesthesiology, Hospital de Manises, Valencia (GM), Department of Biostatistics, Hospital General Universitario Gregorio Marañón, Madrid (JMB), Department of Anaesthesiology, Hospital Universitari i Politécnic La Fe (OD-C), Perioperative Medicine Research Group Instituto de Investigación Sanitaria La Fe (IIS laFe), Valencia (GM, OD-C) and Pharmacology and Toxicology Department, School of Medicine, Complutense University of Madrid, Madrid, Spain (IG) the Department of Anaesthesiology and Critical Care, Hospital Clinic i Provincial, Barcelona, Spain (CF), CIBER de Enfermedades Respiratorias. Instituto de Salud Carlos III, Madrid, Spain (CF).

Background: In intermediate-to-high-risk patients, major abdominal surgery is associated with a high incidence of postoperative complications, mainly pulmonary. Neuromuscular blocking drugs have been suggested as a contributing factor, but this remains unproven.

Objective: To define the relationship of neuromuscular blockade management (reversal) with postoperative pulmonary complications (PPCs).

Design: The individualised PeRioperative Open-lung approach Versus standard protectivE ventilation in abdominal surgery study was a prospective, multicentre, four-arm, randomised controlled trial. This is a secondary analysis of the data.

Setting: Twenty-one teaching hospitals in Spain. The study was conducted between 2 January 2015, and 18 May 2016.

Patients: Age more than 18 years with an intermediate-to-high risk for PPCs, scheduled for major abdominal surgery lasting more than 2 h. Exclusion criteria included pregnancy or breastfeeding, and moderate-to-severe organ diseases.

Interventions: The mode of reversal of neuromuscular blockade determined two patient groups: pharmacological reversal versus spontaneous recovery.

Main Outcome Measures: The primary outcome was a composite of PPCs during the first 30 postoperative days. The association between categorical variables and PPCs within 30 days was studied. Univariate and multivariable logistic regression modelling and propensity score analyses were performed.

Results: From the 923 patients included, 596 (64.6%) presented with PPCs within 30 days after surgery. Patients who developed these complications were older with a higher BMI, a lower pre-operative SpO2, a higher ASA physical status score and a higher incidence of arterial hypertension, diabetes mellitus or chronic obstructive pulmonary disease. Pharmacological neuromuscular blockade reversal was associated with a lower incidence of PPCs (odds ratio 0.62, 95% CI 0.47 to 0.82).

Conclusion: Spontaneous recovery of neuromuscular blockade was an independent risk factor for PPCs in patients with intermediate-to-high risk, undergoing abdominal surgery. We suggest this factor should be included in future studies on PPCs.

Trial Registration: clinicaltrials.gov identifier: NCT02158923.
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http://dx.doi.org/10.1097/EJA.0000000000001128DOI Listing
March 2020

A noninvasive postoperative clinical score to identify patients at risk for postoperative pulmonary complications: the Air-Test Score.

Minerva Anestesiol 2020 04 4;86(4):404-415. Epub 2019 Dec 4.

Department of Anesthesiology and Critical Care, Clinical Hospital of Valencia, Valencia, Spain.

Background: Postoperative pulmonary complications (PPCs) negatively affect morbidity, healthcare costs and postsurgical survival. Preoperative and intraoperative peripheral oxyhemoglobin saturation (SpO2) levels are independent risk factors for postoperative pulmonary complications (PPCs). The air-test assesses the value of SpO2 while breathing room-air. We aimed at building a clinical score that includes the air-test for predicting the risk for PPCs.

Methods: This is a development and validation study in patients -randomly divided into two cohorts- from a large randomized clinical trial (iPROVE) that enrolled 964 intermediate-to-high risk patients scheduled for abdominal surgery. Arterial oxygenation was assessed on room-air in the preoperative period (preoperative air-test) and 3h after admission to the postoperative care unit (postoperative air-test). The air-test was defined as positive or negative if SpO2 was ≤96% or >96%, respectively. Positive air-tests were stratified into weak (93-96%) or strong (<93%). The primary outcome was a composite of moderate-to-severe PPCs during the first seven postoperative days.

Results: A total of 902 patients were included in the final analysis (542 in the development cohort and 360 in the validation cohort). Regression analysis identified five independent risk factors for PPC: age, type of surgery, pre- and postoperative air-test, and atelectasis. The area under the receiver operating characteristic curve (AUC) was 0.79 (95% CI: 0.75-0.82) when including these five independent predictors. We built a simplified score termed "air-test score" by using only the pre- and postoperative SpO2, resulting in an AUC of 0.72 (95% CI: 0.67-0.76) for the derivation and 0.72 (95% CI: 0.66-0.78) for the validation cohort, respectively. The air-test score stratified patients into four levels of risk, with PPCs ranging from <15% to >75%.

Conclusions: The simple, non-invasive and inexpensive bedside air-test score, evaluating pre- and postoperatively SpO2 measured on room-air, helps to predict the risk for PPCs.
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http://dx.doi.org/10.23736/S0375-9393.19.13932-6DOI Listing
April 2020

Effects of oxygen on post-surgical infections during an individualised perioperative open-lung ventilatory strategy: a randomised controlled trial.

Br J Anaesth 2020 01 22;124(1):110-120. Epub 2019 Nov 22.

Department of Anesthesiology and Critical Care, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain.

Background: We aimed to examine whether using a high fraction of inspired oxygen (FIO) in the context of an individualised intra- and postoperative open-lung ventilation approach could decrease surgical site infection (SSI) in patients scheduled for abdominal surgery.

Methods: We performed a multicentre, randomised controlled clinical trial in a network of 21 university hospitals from June 6, 2017 to July 19, 2018. Patients undergoing abdominal surgery were randomly assigned to receive a high (0.80) or conventional (0.3) FIO during the intraoperative period and during the first 3 postoperative hours. All patients were mechanically ventilated with an open-lung strategy, which included recruitment manoeuvres and individualised positive end-expiratory pressure for the best respiratory-system compliance, and individualised continuous postoperative airway pressure for adequate peripheral oxyhaemoglobin saturation. The primary outcome was the prevalence of SSI within the first 7 postoperative days. The secondary outcomes were composites of systemic complications, length of intensive care and hospital stay, and 6-month mortality.

Results: We enrolled 740 subjects: 371 in the high FIO group and 369 in the low FIO group. Data from 717 subjects were available for final analysis. The rate of SSI during the first postoperative week did not differ between high (8.9%) and low (9.4%) FIO groups (relative risk [RR]: 0.94; 95% confidence interval [CI]: 0.59-1.50; P=0.90]). Secondary outcomes, such as atelectasis (7.7% vs 9.8%; RR: 0.77; 95% CI: 0.48-1.25; P=0.38) and myocardial ischaemia (0.6% [n=2] vs 0% [n=0]; P=0.47) did not differ between groups.

Conclusions: An oxygenation strategy using high FIO compared with conventional FIO did not reduce postoperative SSIs in abdominal surgery. No differences in secondary outcomes or adverse events were found.

Clinical Trial Registration: NCT02776046.
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http://dx.doi.org/10.1016/j.bja.2019.10.009DOI Listing
January 2020

Intraoperative Ventilation Strategies to Reduce Pulmonary Complications in Obese Patients.

JAMA 2019 11;322(18):1828

Department of Critical Care Medicine, Hospital Universitario de La Princesa, Madrid, Spain.

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http://dx.doi.org/10.1001/jama.2019.14394DOI Listing
November 2019

Prospective observational study of the effectiveness of prewarming on perioperative hypothermia in surgical patients submitted to spinal anesthesia.

Sci Rep 2019 11 11;9(1):16477. Epub 2019 Nov 11.

Department of Anesthesiology, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain.

Prewarming has been shown to prevent intraoperative inadvertent hypothermia. Nevertheless, data about optimal prewarming-time from published clinical trials report contradictory results. We conducted this pilot study to evaluate routine clinical practice regarding prewarming and its effect on the prevalence of perioperative hypothermia in patients undergoing transurethral resection (TUR) under spinal anesthesia. This was a prospective, observational, pilot study to examine clinical practice in a tertiary hospital regarding prewarming in 140 consecutive patients. When prewarming (pw) was performed, forced-air warming was provided in the pre-anesthesia room for 15 (pw15), 30 (pw30), or 45 (pw45) min. Tympanic temperature was recorded upon entering the pre-anesthesia room, at the time of initiating surgery, and every 15 min intra-operatively. We also recorded duration of the surgical procedure and length of stay in the Post-Anesthesia Care Unit (PACU). Pw15 was performed in 34 patients, pw30 in 29 patients, and pw45 in 21 patients. Fifty-six patients did not receive pw and 96% of them developed hypothermia at the end of the surgical procedure, compared to 73% of patients in pw15 (p = 0.002), 75% in pw30 (p = 0.006) and 90% in pw45 (p = 0.3). Length of stay in the PACU was markedly shorter in pw15 (131 ± 69 min) and pw30 (123 ± 60 min) than in the non-pw group (197 ± 105 min) (p = 0.015 and p = 0.011, respectively). This difference was not significant in pw45 (129 ± 56 min) compared to non-pw patients. In conclusion, prewarming for 15 or 30 min before TUR under spinal anesthesia prevents development of hypothermia at the end of the surgical procedure.
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http://dx.doi.org/10.1038/s41598-019-52960-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6848102PMC
November 2019

Multimodal non-invasive monitoring to apply an open lung approach strategy in morbidly obese patients during bariatric surgery.

J Clin Monit Comput 2020 Oct 25;34(5):1015-1024. Epub 2019 Oct 25.

CIBERES, Madrid, Spain.

To evaluate the use of non-invasive variables for monitoring an open-lung approach (OLA) strategy in bariatric surgery. Twelve morbidly obese patients undergoing bariatric surgery received a baseline protective ventilation with 8 cmHO of positive-end expiratory pressure (PEEP). Then, the OLA strategy was applied consisting in lung recruitment followed by a decremental PEEP trial, from 20 to 8 cmHO, in steps of 2 cmHO to find the lung's closing pressure. Baseline ventilation was then resumed setting open lung PEEP (OL-PEEP) at 2 cmHO above this pressure. The multimodal non-invasive variables used for monitoring OLA consisted in pulse oximetry (SpO), respiratory compliance (Crs), end-expiratory lung volume measured by a capnodynamic method (EELV), and esophageal manometry. OL-PEEP was detected at 15.9 ± 1.7 cmHO corresponding to a positive end-expiratory transpulmonary pressure (P) of 0.9 ± 1.1 cmHO. ROC analysis showed that SpO was more accurate (AUC 0.92, IC95% 0.87-0.97) than Crs (AUC 0.76, IC95% 0.87-0.97) and EELV (AUC 0.73, IC95% 0.64-0.82) to detect the lung's closing pressure according to the change of P from positive to negative values. Compared to baseline ventilation with 8 cmHO of PEEP, OLA increased EELV (1309 ± 517 vs. 2177 ± 679 mL) and decreased driving pressure (18.3 ± 2.2 vs. 10.1 ± 1.7 cmHO), estimated shunt (17.7 ± 3.4 vs. 4.2 ± 1.4%), lung strain (0.39 ± 0.07 vs. 0.22 ± 0.06) and lung elastance (28.4 ± 5.8 vs. 15.3 ± 4.3 cmHO/L), respectively; all p < 0.0001. The OLA strategy can be monitored using noninvasive variables during bariatric surgery. This strategy decreased lung strain, elastance and driving pressure compared with standard protective ventilatory settings.Clinical trial number NTC03694665.
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http://dx.doi.org/10.1007/s10877-019-00405-wDOI Listing
October 2020

PEEP titration guided by transpulmonary pressure: lessons from a negative trial.

J Thorac Dis 2019 Sep;11(Suppl 15):S1957-S1962

CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.

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http://dx.doi.org/10.21037/jtd.2019.08.03DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6783792PMC
September 2019

High-flow nasal cannula oxygenation reduces postoperative hypoxemia in morbidly obese patients: a randomized controlled trial.

Minerva Anestesiol 2019 Oct 16;85(10):1062-1070. Epub 2019 Apr 16.

Department of Anesthesiology and Critical Care, Clinical University Hospital, Valencia, Spain.

Background: Postoperative pulmonary complications (PPCs) are common in high-risk surgical patients. Postoperative ventilatory management may improve their outcome. Supplemental oxygen through a high-flow nasal cannula (HFNC) has become an alternative to classical oxygenation techniques, although the results published for postoperative patients are contradictory. We examined the efficacy of HFNC in postoperative morbidly obese patients who were ventilated intraoperatively with an open-lung approach (OLA).

Methods: We performed an open, two-arm, randomized controlled trial in 64 patients undergoing bariatric surgery (N.=32 in each arm) from May to November 2017 at the Hospital Clínico of Valencia. Patients were randomly assigned to receive HFNC oxygen therapy at the time of extubation or to receive conventional oxygen therapy, both applied during the first three postoperative hours. Intraoperatively, a recruitment maneuver and individualized positive end-expiratory pressure was applied in all patients. The primary outcome was postoperative hypoxemia.

Results: All patients were included in the final analysis. There were no significant differences between the baseline characteristics. Postoperative hypoxemia was less frequent in the HFNC group compared to those who received standard care (28.6% vs. 80.0%, relative risk [RR]: 0.35; 95%CI: 0.150-0.849, P=0.009). Prevalence of atelectasis was lower in the HFNC group (31% vs. 77%, RR: 0.39; 95%CI: 0.166-0.925, P=0.013). No severe PPCs were reported in any patient.

Conclusions: Early application of HFNC in the operating room before extubation and during the immediate postoperative period decreases postoperative hypoxemia in obese patients after bariatric surgery who were intraoperatively ventilated using an OLA approach.
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http://dx.doi.org/10.23736/S0375-9393.19.13364-0DOI Listing
October 2019

Rationale and Study Design for an Individualized Perioperative Open Lung Ventilatory Strategy in Patients on One-Lung Ventilation (iPROVE-OLV).

J Cardiothorac Vasc Anesth 2019 Sep 8;33(9):2492-2502. Epub 2019 Feb 8.

Department of Anesthesia and Critical Care, Università di Foggia, Foggia, Italy.

Objective: The aim of this clinical trial is to examine whether it is possible to reduce postoperative complications using an individualized perioperative ventilatory strategy versus using a standard lung-protective ventilation strategy in patients scheduled for thoracic surgery requiring one-lung ventilation.

Design: International, multicenter, prospective, randomized controlled clinical trial.

Setting: A network of university hospitals.

Participants: The study comprises 1,380 patients scheduled for thoracic surgery.

Interventions: The individualized group will receive intraoperative recruitment maneuvers followed by individualized positive end-expiratory pressure (open lung approach) during the intraoperative period plus postoperative ventilatory support with high-flow nasal cannula, whereas the control group will be managed with conventional lung-protective ventilation.

Measurements And Main Results: Individual and total number of postoperative complications, including atelectasis, pneumothorax, pleural effusion, pneumonia, acute lung injury; unplanned readmission and reintubation; length of stay and death in the critical care unit and in the hospital will be analyzed for both groups. The authors hypothesize that the intraoperative application of an open lung approach followed by an individual indication of high-flow nasal cannula in the postoperative period will reduce pulmonary complications and length of hospital stay in high-risk surgical patients.
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http://dx.doi.org/10.1053/j.jvca.2019.01.056DOI Listing
September 2019

The quest for the perfect Weaning Index.

Minerva Anestesiol 2019 04 12;85(4):336-337. Epub 2019 Mar 12.

Department of Anesthesiology and Critical Care, University of Valencia, Valencia, Spain.

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http://dx.doi.org/10.23736/S0375-9393.19.13593-6DOI Listing
April 2019

A Prognostic Enrichment Strategy for Selection of Patients With Acute Respiratory Distress Syndrome in Clinical Trials.

Crit Care Med 2019 03;47(3):377-385

Department of Respiratory Care, Massachusetts General Hospital, Boston, MA.

Objectives: Incomplete or ambiguous evidence for identifying high-risk patients with acute respiratory distress syndrome for enrollment into randomized controlled trials has come at the cost of an unreasonable number of negative trials. We examined a set of selected variables early in acute respiratory distress syndrome to determine accurate prognostic predictors for selecting high-risk patients for randomized controlled trials.

Design: A training and testing study using a secondary analysis of data from four prospective, multicenter, observational studies.

Setting: A network of multidisciplinary ICUs.

Patients: We studied 1,200 patients with moderate-to-severe acute respiratory distress syndrome managed with lung-protective ventilation.

Interventions: None.

Measurements And Main Results: We evaluated different thresholds for patient's age, PaO2/FIO2, plateau pressure, and number of extrapulmonary organ failures to predict ICU outcome at 24 hours of acute respiratory distress syndrome diagnosis. We generated 1,000 random scenarios as training (n = 900, 75% of population) and testing (n = 300, 25% of population) datasets and averaged the logistic coefficients for each scenario. Thresholds for age (< 50, 50-70, > 70 yr), PaO2/FIO2 (≤ 100, 101-150, > 150 mm Hg), plateau pressure (< 29, 29-30, > 30 cm H2O), and number of extrapulmonary organ failure (< 2, 2, > 2) stratified accurately acute respiratory distress syndrome patients into categories of risk. The model that included all four variables proved best to identify patients with the highest or lowest risk of death (area under the receiver operating characteristic curve, 0.86; 95% CI, 0.84-0.88). Decision tree analyses confirmed the accuracy and robustness of this enrichment model.

Conclusions: Combined thresholds for patient's age, PaO2/FIO2, plateau pressure, and extrapulmonary organ failure provides prognostic enrichment accuracy for stratifying and selecting acute respiratory distress syndrome patients for randomized controlled trials.
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http://dx.doi.org/10.1097/CCM.0000000000003624DOI Listing
March 2019

The Effects of an Open-Lung Approach During One-Lung Ventilation on Postoperative Pulmonary Complications and Driving Pressure: A Descriptive, Multicenter National Study.

J Cardiothorac Vasc Anesth 2018 12 27;32(6):2665-2672. Epub 2018 Mar 27.

Hospital Gregorio Marañón de Madrid, Madrid, Spain.

Objective: Thoracic surgical procedures are associated with an increased risk of postoperative pulmonary complications (PPCs), which seem to be related directly to intraoperative driving pressure. The authors conducted this study to describe the incidence of PPCs in patients in whom an individualized open-lung approach was applied during one-lung ventilation.

Design: This was a prospective, multicenter, national descriptive study.

Setting: Thoracic surgery patients undergoing one-lung ventilation.

Participants: Eligible participants were included consecutively from October 1, 2016, to September 30, 2017. A total of 690 patients were included.

Interventions: An individualized open-lung approach that consisted of an alveolar recruitment maneuver followed by a positive end-expiratory pressure adjusted to best respiratory system compliance was performed in all patients.

Measurements And Main Results: Preoperative and intraoperative data were recorded; the primary outcome was a description of the incidence of PPCs in these patients during the first 7 postoperative days. The patients were mainly male, and half of them had a high risk of PPCs (ARISCAT score exceeding 44). Eleven percent of participants developed a PPC within the first postoperative week. The mean open lung positive end-expiratory pressure was 8 ± 3 cmHO. When compared with pre-open lung approach values, the open-lung approach significantly decreased the driving pressure (14 ± 4 cmHO v 11 ± 3 cmHO; p < 0.001) and increased dynamic compliance (30 ± 10 mL/cmHO v 43 ±15 mL/cmHO; p < 0.001).

Conclusions: The low incidence of PPCs in patients who underwent an open-lung approach during one-lung ventilation compared with that reported for other thoracic surgery series and the decrease in the driving pressure in these patients justify an additional randomized controlled trial to compare the open-lung approach with the standard protective strategy of low tidal volume and low positive end-expiratory pressure.
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http://dx.doi.org/10.1053/j.jvca.2018.03.028DOI Listing
December 2018

Is Overall Mortality the Right Composite Endpoint in Clinical Trials of Acute Respiratory Distress Syndrome?

Crit Care Med 2018 06;46(6):892-899

Department of Respiratory Care, Massachusetts General Hospital, Boston, MA.

Objectives: Overall mortality in patients with acute respiratory distress syndrome is a composite endpoint because it includes death from multiple causes. In most acute respiratory distress syndrome trials, it is unknown whether reported deaths are due to acute respiratory distress syndrome or the underlying disease, unrelated to the specific intervention tested. We investigated the causes of death after contracting acute respiratory distress syndrome in a large cohort.

Design: A secondary analysis from three prospective, multicenter, observational studies.

Setting: A network of multidisciplinary ICUs.

Patients: We studied 778 patients with moderate-to-severe acute respiratory distress syndrome treated with lung-protective ventilation.

Interventions: None.

Measurements And Main Results: We examined death in the ICU from individual causes. Overall ICU mortality was 38.8% (95% CI, 35.4-42.3). Causes of acute respiratory distress syndrome modified the risk of death. Twenty-three percent of deaths occurred from refractory hypoxemia due to nonresolving acute respiratory distress syndrome. Most patients died from causes unrelated to acute respiratory distress syndrome: 48.7% of nonsurvivors died from multisystem organ failure, and cancer or brain injury was involved in 37.1% of deaths. When quantifying the true burden of acute respiratory distress syndrome outcome, we identified 506 patients (65.0%) with one or more exclusion criteria for enrollment into current interventional trials. Overall ICU mortality of the "trial cohort" (21.3%) was markedly lower than the parent cohort (relative risk, 0.55; 95% CI, 0.43-0.70; p < 0.000001).

Conclusions: Most deaths in acute respiratory distress syndrome patients are not directly related to lung damage but to extrapulmonary multisystem organ failure. It would be challenging to prove that specific lung-directed therapies have an effect on overall survival.
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http://dx.doi.org/10.1097/CCM.0000000000003022DOI Listing
June 2018

Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial.

Lancet Respir Med 2018 03 19;6(3):193-203. Epub 2018 Jan 19.

Department of Anesthesiology, Hospital NS de Candelaria, Santa Cruz de Tenerife, Spain.

Background: The effects of individualised perioperative lung-protective ventilation (based on the open-lung approach [OLA]) on postoperative complications is unknown. We aimed to investigate the effects of intraoperative and postoperative ventilatory management in patients scheduled for abdominal surgery, compared with standard protective ventilation.

Methods: We did this prospective, multicentre, randomised controlled trial in 21 teaching hospitals in Spain. We enrolled patients who were aged 18 years or older, were scheduled to have abdominal surgery with an expected time of longer than 2 h, had intermediate-to-high-risk of developing postoperative pulmonary complications, and who had a body-mass index less than 35 kg/m. Patients were randomly assigned (1:1:1:1) online to receive one of four lung-protective ventilation strategies using low tidal volume plus positive end-expiratory pressure (PEEP): open-lung approach (OLA)-iCPAP (individualised intraoperative ventilation [individualised PEEP after a lung recruitment manoeuvre] plus individualised postoperative continuous positive airway pressure [CPAP]), OLA-CPAP (intraoperative individualised ventilation plus postoperative CPAP), STD-CPAP (standard intraoperative ventilation plus postoperative CPAP), or STD-O (standard intraoperative ventilation plus standard postoperative oxygen therapy). Patients were masked to treatment allocation. Investigators were not masked in the operating and postoperative rooms; after 24 h, data were given to a second investigator who was masked to allocations. The primary outcome was a composite of pulmonary and systemic complications during the first 7 postoperative days. We did the primary analysis using the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02158923.

Findings: Between Jan 2, 2015, and May 18, 2016, we enrolled 1012 eligible patients. Data were available for 967 patients, whom we included in the final analysis. Risk of pulmonary and systemic complications did not differ for patients in OLA-iCPAP (110 [46%] of 241, relative risk 0·89 [95% CI 0·74-1·07; p=0·25]), OLA-CPAP (111 [47%] of 238, 0·91 [0·76-1·09; p=0·35]), or STD-CPAP groups (118 [48%] of 244, 0·95 [0·80-1·14; p=0·65]) when compared with patients in the STD-O group (125 [51%] of 244). Intraoperatively, PEEP was increased in 69 (14%) of patients in the standard perioperative ventilation groups because of hypoxaemia, and no patients from either of the OLA groups required rescue manoeuvres.

Interpretation: In patients who have major abdominal surgery, the different perioperative open lung approaches tested in this study did not reduce the risk of postoperative complications when compared with standard lung-protective mechanical ventilation.

Funding: Instituto de Salud Carlos III of the Spanish Ministry of Economy and Competitiveness, and Grants Programme of the European Society of Anaesthesiology.
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http://dx.doi.org/10.1016/S2213-2600(18)30024-9DOI Listing
March 2018

Managing Persistent Hypoxemia: what is new?

F1000Res 2017 13;6:1993. Epub 2017 Nov 13.

Department of Respiratory Care, Massachusetts General Hospital, Boston, Massuchusetts, USA.

Mechanical ventilation is the standard life-support technique for patients with severe acute respiratory failure. However, some patients develop persistent and refractory hypoxemia because their lungs are so severely damaged that they are unable to respond to the application of high inspired oxygen concentration and high levels of positive end-expiratory pressure. In this article, we review current knowledge on managing persistent hypoxemia in patients with injured lungs.
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http://dx.doi.org/10.12688/f1000research.11760.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5686475PMC
November 2017

Postural lung recruitment assessed by lung ultrasound in mechanically ventilated children.

Crit Ultrasound J 2017 Oct 13;9(1):22. Epub 2017 Oct 13.

Hedenstierna Laboratory, Department of Surgical Sciences, Section of Anesthesia and Critical Care, Uppsala University Hospital, Uppsala, Sweden.

Background: Atelectasis is a common finding in mechanically ventilated children with healthy lungs. This lung collapse cannot be overcome using standard levels of positive end-expiratory pressure (PEEP) and thus for only individualized lung recruitment maneuvers lead to satisfactory therapeutic results. In this short communication, we demonstrate by lung ultrasound images (LUS) the effect of a postural recruitment maneuver (P-RM, i.e., a ventilatory strategy aimed at reaerating atelectasis by changing body position under constant ventilation).

Results: Data was collected in the operating room of the Hospital Privado de Comunidad, Mar del Plata, Argentina. Three anesthetized children undergoing mechanical ventilation at constant settings were sequentially subjected to the following two maneuvers: (1) PEEP trial in the supine position PEEP was increased to 10 cmHO for 3 min and then decreased to back to baseline. (2) P-RM patient position was changed from supine to the left and then to the right lateral position for 90 s each before returning to supine. The total P-RM procedure took approximately 3 min. LUS in the supine position showed similar atelectasis before and after the PEEP trial. Contrarily, atelectasis disappeared in the non-dependent lung when patients were placed in the lateral positions. Both lungs remained atelectasis free even after returning to the supine position.

Conclusions: We provide LUS images that illustrate the concept and effects of postural recruitment in children. This maneuver has the advantage of achieving recruitment effects without the need to elevate airways pressures.
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http://dx.doi.org/10.1186/s13089-017-0073-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5640559PMC
October 2017
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