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RELAx - REstricted versus Liberal positive end-expiratory pressure in patients without ARDS: protocol for a randomized controlled trial.

Abstract：

BACKGROUND:Evidence for benefit of high positive end-expiratory pressure (PEEP) is largely lacking for invasively ventilated, critically ill patients with uninjured lungs. We hypothesize that ventilation with low PEEP is noninferior to ventilation with high PEEP with regard to the number of ventilator-free days and being alive at day 28 in this population.  METHODS/DESIGN: The "REstricted versus Liberal positive end-expiratory pressure in patients without ARDS" trial (RELAx) is a national, multicenter, randomized controlled, noninferiority trial in adult intensive care unit (ICU) patients with uninjured lungs who are expected not to be extubated within 24 h. RELAx will run in 13 ICUs in the Netherlands to enroll 980 patients under invasive ventilation. In all patients, low tidal volumes are used. Patients assigned to ventilation with low PEEP will receive the lowest possible PEEP between 0 and 5 cm H2O, while patients assigned to ventilation with high PEEP will receive PEEP of 8 cm H2O. The primary endpoint is the number of ventilator-free days and being alive at day 28, a composite endpoint for liberation from the ventilator and mortality until day 28, with a noninferiority margin for a difference between groups of 0.5 days. Secondary endpoints are length of stay (LOS), mortality, and occurrence of pulmonary complications, including severe hypoxemia, major atelectasis, need for rescue therapies, pneumonia, pneumothorax, and development of acute respiratory distress syndrome (ARDS). Hemodynamic support and sedation needs will be collected and compared. DISCUSSION:RELAx will be the first sufficiently sized randomized controlled trial in invasively ventilated, critically ill patients with uninjured lungs using a clinically relevant and objective endpoint to determine whether invasive, low-tidal-volume ventilation with low PEEP is noninferior to ventilation with high PEEP. TRIAL REGISTRATION:ClinicalTrials.gov , ID: NCT03167580 . Registered on 23 May 2017.

journal_name

Trials

journal_title

Trials

authors

Algera AG,Pisani L,Bergmans DCJ,den Boer S,de Borgie CAJ,Bosch FH,Bruin K,Cherpanath TG,Determann RM,Dondorp AM,Dongelmans DA,Endeman H,Haringman JJ,Horn J,Juffermans NP,van Meenen DM,van der Meer NJ,Merkus MP,Moenira

doi

10.1186/s13063-018-2640-5

subject

Has Abstract

pub_date

2018-05-09 00:00:00

pages

272

issue

1

issn

1745-6215

pii

10.1186/s13063-018-2640-5

journal_volume

19

pub_type

杂志文章

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