Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/25512
Title: Effect of a Lower vs Higher Positive End-Expiratory Pressure Strategy on Ventilator-Free Days in ICU Patients Without ARDS: A Randomized Clinical Trial.
Austin Authors: Algera, Anna Geke;Pisani, Luigi;Serpa Neto, Ary ;den Boer, Sylvia S;Bosch, Frank F H;Bruin, Karina;Klooster, Pauline M;Van der Meer, Nardo J M;Nowitzky, Ralph O;Purmer, Ilse M;Slabbekoorn, Mathilde;Spronk, Peter E;van Vliet, Jan;Weenink, Jan J;Gama de Abreu, Marcelo;Pelosi, Paolo;Schultz, Marcus J;Paulus, Frederique
Affiliation: Department of Intensive Care and Laboratory of Experimental Intensive Care and Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands
Data Analytics Research and Evaluation (DARE) Centre
Department of Intensive Care and Laboratory of Experimental Intensive Care and Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands
ACHIEVE Centre of Expertise, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, the Netherlands
Nuffield Department of Medicine, Oxford University, Oxford, England
Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand
Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil
Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), Monash University, Melbourne, Victoria, Australia
Department of Intensive Care, Spaarne Gasthuis, Haarlem and Hoofddorp, the Netherlands
Department of Intensive Care, Rijnstate Hospital, Arnhem, the Netherlands
Department of Intensive Care, Westfriesgasthuis, Hoorn, the Netherlands
Department of Intensive Care, Haaglanden MC, the Hague, the Netherlands
Department of Intensive Care, Amphia Hospital, Breda, the Netherlands
Department of Intensive Care, Haga Hospital, the Hague, the Netherlands
Department of Intensive Care, Haaglanden MC, the Hague, the Netherlands
Department of Intensive Care, Gelre Hospitals, Apeldoorn, the Netherlands
Department of Intensive Care, Rijnstate Hospital, Arnhem, the Netherlands
Department of Intensive Care, Spaarne Gasthuis, Haarlem and Hoofddorp, the Netherlands
Department of Anesthesiology and Intensive Care, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Dresden, Germany
Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology, University of Genoa, Genoa, Italy
Issue Date: 9-Dec-2020
Date: 2020-12-22
Publication information: JAMA 2020; 324(24): 2509-2520
Abstract: It is uncertain whether invasive ventilation can use lower positive end-expiratory pressure (PEEP) in critically ill patients without acute respiratory distress syndrome (ARDS). To determine whether a lower PEEP strategy is noninferior to a higher PEEP strategy regarding duration of mechanical ventilation at 28 days. Noninferiority randomized clinical trial conducted from October 26, 2017, through December 17, 2019, in 8 intensive care units (ICUs) in the Netherlands among 980 patients without ARDS expected not to be extubated within 24 hours after start of ventilation. Final follow-up was conducted in March 2020. Participants were randomized to receive invasive ventilation using either lower PEEP, consisting of the lowest PEEP level between 0 and 5 cm H2O (n = 476), or higher PEEP, consisting of a PEEP level of 8 cm H2O (n = 493). The primary outcome was the number of ventilator-free days at day 28, with a noninferiority margin for the difference in ventilator-free days at day 28 of -10%. Secondary outcomes included ICU and hospital lengths of stay; ICU, hospital, and 28- and 90-day mortality; development of ARDS, pneumonia, pneumothorax, severe atelectasis, severe hypoxemia, or need for rescue therapies for hypoxemia; and days with use of vasopressors or sedation. Among 980 patients who were randomized, 969 (99%) completed the trial (median age, 66 [interquartile range {IQR}, 56-74] years; 246 [36%] women). At day 28, 476 patients in the lower PEEP group had a median of 18 ventilator-free days (IQR, 0-27 days) and 493 patients in the higher PEEP group had a median of 17 ventilator-free days (IQR, 0-27 days) (mean ratio, 1.04; 95% CI, 0.95-∞; P = .007 for noninferiority), and the lower boundary of the 95% CI was within the noninferiority margin. Occurrence of severe hypoxemia was 20.6% vs 17.6% (risk ratio, 1.17; 95% CI, 0.90-1.51; P = .99) and need for rescue strategy was 19.7% vs 14.6% (risk ratio, 1.35; 95% CI, 1.02-1.79; adjusted P = .54) in patients in the lower and higher PEEP groups, respectively. Mortality at 28 days was 38.4% vs 42.0% (hazard ratio, 0.89; 95% CI, 0.73-1.09; P = .99) in patients in the lower and higher PEEP groups, respectively. There were no statistically significant differences in other secondary outcomes. Among patients in the ICU without ARDS who were expected not to be extubated within 24 hours, a lower PEEP strategy was noninferior to a higher PEEP strategy with regard to the number of ventilator-free days at day 28. These findings support the use of lower PEEP in patients without ARDS. ClinicalTrials.gov Identifier: NCT03167580.
URI: https://ahro.austin.org.au/austinjspui/handle/1/25512
DOI: 10.1001/jama.2020.23517
Journal: JAMA
PubMed URL: 33295981
Type: Journal Article
Appears in Collections:Journal articles

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