Publications by authors named "Ricard Mellado -Artigas"

11 Publications

  • Page 1 of 1

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

Comment on "Temporal Dynamics of ICP, CPP, PRx, and CPPopt in High-Grade Aneurysmal Subarachnoid Hemorrhage and the Relation to Clinical Outcome".

Neurocrit Care 2021 04 22;34(2):693-694. Epub 2021 Mar 22.

Department of Anesthesiology and Critical Care, Hospital Clínic de Barcelona, Barcelona, Spain.

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http://dx.doi.org/10.1007/s12028-021-01215-2DOI Listing
April 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

Reverse Triggering Dyssynchrony 24 h after Initiation of Mechanical Ventilation.

Anesthesiology 2021 05;134(5):760-769

Background: Reverse triggering is a delayed asynchronous contraction of the diaphragm triggered by passive insufflation by the ventilator in sedated mechanically ventilated patients. The incidence of reverse triggering is unknown. This study aimed at determining the incidence of reverse triggering in critically ill patients under controlled ventilation.

Methods: In this ancillary study, patients were continuously monitored with a catheter measuring the electrical activity of the diaphragm. A method for automatic detection of reverse triggering using electrical activity of the diaphragm was developed in a derivation sample and validated in a subsequent sample. The authors assessed the predictive value of the software. In 39 recently intubated patients under assist-control ventilation, a 1-h recording obtained 24 h after intubation was used to determine the primary outcome of the study. The authors also compared patients' demographics, sedation depth, ventilation settings, and time to transition to assisted ventilation or extubation according to the median rate of reverse triggering.

Results: The positive and negative predictive value of the software for detecting reverse triggering were 0.74 (95% CI, 0.67 to 0.81) and 0.97 (95% CI, 0.96 to 0.98). Using a threshold of 1 μV of electrical activity to define diaphragm activation, median reverse triggering rate was 8% (range, 0.1 to 75), with 44% (17 of 39) of patients having greater than or equal to 10% of breaths with reverse triggering. Using a threshold of 3 μV, 26% (10 of 39) of patients had greater than or equal to 10% reverse triggering. Patients with more reverse triggering were more likely to progress to an assisted mode or extubation within the following 24 h (12 of 39 [68%]) vs. 7 of 20 [35%]; P = 0.039).

Conclusions: Reverse triggering detection based on electrical activity of the diaphragm suggests that this asynchrony is highly prevalent at 24 h after intubation under assist-control ventilation. Reverse triggering seems to occur during the transition phase between deep sedation and the onset of patient triggering.

Editor’s Perspective:
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http://dx.doi.org/10.1097/ALN.0000000000003726DOI Listing
May 2021

Automated detection and quantification of reverse triggering effort under mechanical ventilation.

Crit Care 2021 02 15;25(1):60. Epub 2021 Feb 15.

Keenan Research Centre for Biomedical Science, Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond St, Toronto, ON, M5B 1W8, Canada.

Background: Reverse triggering (RT) is a dyssynchrony defined by a respiratory muscle contraction following a passive mechanical insufflation. It is potentially harmful for the lung and the diaphragm, but its detection is challenging. Magnitude of effort generated by RT is currently unknown. Our objective was to validate supervised methods for automatic detection of RT using only airway pressure (Paw) and flow. A secondary objective was to describe the magnitude of the efforts generated during RT.

Methods: We developed algorithms for detection of RT using Paw and flow waveforms. Experts having Paw, flow and esophageal pressure (Pes) assessed automatic detection accuracy by comparison against visual assessment. Muscular pressure (Pmus) was measured from Pes during RT, triggered breaths and ineffective efforts.

Results: Tracings from 20 hypoxemic patients were used (mean age 65 ± 12 years, 65% male, ICU survival 75%). RT was present in 24% of the breaths ranging from 0 (patients paralyzed or in pressure support ventilation) to 93.3%. Automatic detection accuracy was 95.5%: sensitivity 83.1%, specificity 99.4%, positive predictive value 97.6%, negative predictive value 95.0% and kappa index of 0.87. Pmus of RT ranged from 1.3 to 36.8 cmH0, with a median of 8.7 cmH0. RT with breath stacking had the highest levels of Pmus, and RTs with no breath stacking were of similar magnitude than pressure support breaths.

Conclusion: An automated detection tool using airway pressure and flow can diagnose reverse triggering with excellent accuracy. RT generates a median Pmus of 9 cmHO with important variability between and within patients.

Trial Registration: BEARDS, NCT03447288.
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http://dx.doi.org/10.1186/s13054-020-03387-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7883535PMC
February 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

Edema Resolution and Clinical Assessment in Poor-Grade Subarachnoid Hemorrhage: Useful Indicators to Predict Delayed Cerebral Infarctions?

J Clin Med 2021 Jan 17;10(2). Epub 2021 Jan 17.

Neurological Surgery Department, Hospital Clinic of Barcelona, 08036 Barcelona, Spain.

Background: The level of consciousness and cerebral edema are among the indicators that best define the intensity of early brain injury following aneurysmal subarachnoid hemorrhage (aSAH). Although these indicators are usually altered in patients with a poor neurological status, their usefulness for selecting patients at risk of cerebral infarction (CI) is not well established. Furthermore, little is known about the evolution of these indicators during the first week of post-ictal events. Our study focused on describing the association of the longitudinal course of these predictors with CI occurrence in patients with severe aSAH.

Methods: Out of 265 aSAH patients admitted consecutively to the same institution, 80 patients with initial poor neurological status (WFNS 4-5) were retrospectively identified. After excluding 25 patients with early mortality, a total of 47 patients who underwent early CT (<3 days) and late CT (<7 days) acquisitions were included in the study. Early cerebral edema and delayed cerebral edema were calculated using the SEBES score, and the level of consciousness was recorded daily during the first week using the Glasgow Coma Scale (GCS).

Results: There was a significant improvement in the SEBES (Early-SEBES median (IQR) = 3 (2-4) versus Delayed-SEBES = 2 (1-3); = 0.001) and in GCS scores (B = 0.32; 95% CI 0.15-0.49; = 0.001) during the first week. When comparing the ROC curves of Delayed-SEBES vs Early-SEBES as predictors of CI, no significant differences were found (Early-SEBES Area Under the Curve: 0.65; Delayed-SEBES: 0.62; = 0.17). Additionally, no differences were observed in the relationship between the improvement in the GCS across the first week and the occurrence of CI ( = 0.536).

Conclusions: Edema and consciousness level improvement did not seem to be associated with the occurrence of CI in a surviving cohort of patients with severe aSAH. Our results suggest that intensive monitoring should not be reduced in patients with a poor neurological status regardless of an improvement in cerebral edema and level of consciousness during the first week after bleeding.
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http://dx.doi.org/10.3390/jcm10020321DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7830766PMC
January 2021

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

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
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