RELAx – REstricted versus Liberal positive end-expiratory pressure in patients without ARDS: protocol for a randomized controlled trial
Posted on 2018-05-09 - 05:00
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.
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Algera, Anna; Pisani, Luigi; Bergmans, Dennis; den Boer, Sylvia; de Borgie, Corianne; Bosch, Frank; et al. (2018). RELAx – REstricted versus Liberal positive end-expiratory pressure in patients without ARDS: protocol for a randomized controlled trial. figshare. Collection. https://doi.org/10.6084/m9.figshare.c.4093472.v1
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AUTHORS (29)
AA
Anna Algera
LP
Luigi Pisani
DB
Dennis Bergmans
Sd
Sylvia den Boer
Cd
Corianne de Borgie
FB
Frank Bosch
KB
Karina Bruin
TC
Thomas Cherpanath
RD
Rogier Determann
AD
Arjen Dondorp
DD
Dave Dongelmans
HE
Henrik Endeman
JH
Jasper Haringman
JH
Janneke Horn
NJ
Nicole Juffermans
Dv
David van Meenen
Nv
Nardo van der Meer
MM
Maruschka Merkus
HM
Hazra Moeniralam
IP
Ilse Purmer