Effect of a Lower vs Higher Positive End-Expiratory Pressure Strategy on Ventilator-Free Days in ICU Patients Without ARDS A Randomized Clinical Trial

被引:40
作者
Algera, Anna Geke [1 ,2 ]
Pisani, Luigi [1 ,2 ]
Serpa Neto, Ary [3 ,4 ,5 ,6 ]
den Boer, Sylvia S. [7 ,8 ]
Bosch, Frank F. H. [9 ]
Bruin, Karina [10 ]
Klooster, Pauline M. [11 ]
van der Meer, Nardo J. M. [12 ]
Nowitzky, Ralph O. [13 ]
Purmer, Ilse M. [13 ]
Slabbekoorn, Mathilde [11 ]
Spronk, Peter E. [14 ]
van Vliet, Jan [9 ]
Weenink, Jan J. [7 ,8 ]
Gama de Abreu, Marcelo [15 ]
Pelosi, Paolo [16 ]
Schultz, Marcus J. [1 ,2 ,17 ,18 ]
Paulus, Frederique [1 ,2 ,19 ]
机构
[1] Amsterdam UMC, Dept Intens Care, Amsterdam, Netherlands
[2] Amsterdam UMC, Lab Expt Intens Care & Anesthesiol, Amsterdam, Netherlands
[3] Hosp Israelita Albert Einstein, Dept Crit Care Med, Sao Paulo, Brazil
[4] Monash Univ, Australian & New Zealand Intens Care Res Ctr ANZI, Melbourne, Vic, Australia
[5] Austin Hosp, Data Analyt Res & Evaluat DARE Ctr, Melbourne, Vic, Australia
[6] Univ Melbourne, Melbourne, Vic, Australia
[7] Spaarne Gasthuis, Dept Intens Care, Haarlem, Netherlands
[8] Spaarne Gasthuis, Dept Intens Care, Hoofddorp, Netherlands
[9] Rijnstate Hosp, Dept Intens Care, Arnhem, Netherlands
[10] Westfriesgasthuis, Dept Intens Care, Hoorn, Netherlands
[11] Haaglanden MC, Dept Intens Care, The Hague, Netherlands
[12] Amphia Hosp, Dept Intens Care, Breda, Netherlands
[13] Haga Hosp, Dept Intens Care, The Hague, Netherlands
[14] Gelre Hosp, Dept Intens Care, Apeldoorn, Netherlands
[15] Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care, Pulm Engn Grp, Dresden, Germany
[16] Univ Genoa, Dept Surg Sci & Integrated Diagnost, San Martino Policlin Hosp, IRCCS Oncol, Genoa, Italy
[17] Univ Oxford, Nuffield Dept Med, Oxford, England
[18] Mahidol Univ, Mahidol Oxford Trop Med Res Unit MORU, Bangkok, Thailand
[19] Amsterdam Univ Appl Sci, Fac Hlth, ACHIEVE Ctr Expertise, Amsterdam, Netherlands
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2020年 / 324卷 / 24期
关键词
RESPIRATORY-DISTRESS-SYNDROME; INTENSIVE-CARE-UNIT; OXYGEN-THERAPY; LUNG INJURY; MULTICENTER; PNEUMONIA; MORTALITY;
D O I
10.1001/jama.2020.23517
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
IMPORTANCE: It is uncertain whether invasive ventilation can use lower positive end-expiratory pressure (PEEP) in : critically ill patients without acute respiratory distress syndrome (ARDS). OBJECTIVE: To determine whether a lower PEEP strategy is noninferior to a higher PEEP strategy regarding duration of mechanical ventilation at 28 days. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTIONS: 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). MAIN OUTCOMES AND MEASURES: 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. RESULTS: 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-infinity; 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. CONCLUSIONS AND RELEVANCE: 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.
引用
收藏
页码:2509 / 2520
页数:12
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