REstricted Versus Liberal Positive End-Expiratory Pressure in Patients Without ARDS
RELAx
RELAx
Sponsor study identifier
interventional
980
1 country
13
Study Start
October 26, 2017
Actual (reported)Primary Completion
January 14, 2020
Actual (reported)Study Completion
March 16, 2020
Actual (reported)The 'REstricted versus Liberal positive end-expiratory pressure in patients without Acute respiratory distress syndrome' (RELAx) trial is a national multicenter, open randomized controlled trial in ICU patients without ARDS at start of ventilation. It will be the first RCT comparing ventilation with the lowest possible positive end-expiratory pressure (PEEP) level with ventilation with the median PEEP level currently practiced in the Netherlands that recruits a sufficient number of patients to test the hypothesis that ventilation with the lowest possible PEEP level is non-inferior to ventilation with a PEEP level of 8 cm H2O with regard to objective and patient-relevant clinical endpoints.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 16, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 23, 2017
Actual (reported)May 30, 2017
Actual (reported)October 26, 2017
Actual (reported)January 14, 2020
Actual (reported)March 16, 2020
Actual (reported)Ventilation-free days and alive at day 28
The number of ventilation-free days, defined as the number of days from day 1 to day 28; the patient is alive and breathes without assistance of the mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours.
first 28 days after start of ventilation
Length of stay
first 90 days after start of ventilation
Mortality
first 90 days after start of ventilation
Pulmonary complications
daily until detubation or day 28
Rescue strategies for severe hypoxemia or severe atelectasis
daily until detubation or day 28
Days with use of hemodynamic support
daily until detubation or day 28
Use of the restricted PEEP level (0 - 5 cm H2O, the lowest possible PEEP level) after intubation and during all mechanical ventilation.
Use of the liberal PEEP level (8 cm H2O) after intubation and during all mechanical ventilation.
Patients are randomized and ventilated with restricted PEEP (the lowest possible PEEP level, 0 - 5 cm H2O)
Patients are randomized and ventilated with liberal PEEP (the median PEEP level used in the Netherlands, 8 cm H2O)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
VU Medical Center
Amsterdam, Netherlands
Gelre Hospital
Apeldoorn, Netherlands
Rijnstate
Arnhem, Netherlands
Amphia Hospital
Breda, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Caroli A, Algera AG, van Meenen D, Schultz MJ, Paulus F, Neto AS; REstricted vs. Liberal positive end-expiratory pressure in patients without Acute Respiratory Distress Syndrome (RELAx)-investigators and the PRotective Ventilation (PROVE) Network. Effect of a Lower Vs. Higher Positive End-Expiratory Pressure Strategy on Clinically Relevant Outcomes in ICU Patients Without Acute Respiratory Distress Syndrome: Bayesian Re-analysis of the REstricted Vs. Liberal Positive End-Expiratory Pressure in Patients Without Acute Respiratory Distress Syndrome (RELAx) Randomized Clinical Trial. Crit Care Med. 2026 Jun 1;54(6):1431-1441. doi: 10.1097/CCM.0000000000007117. Epub 2026 Mar 31.
van Meenen DMP, Algera AG, Schuijt MTU, Simonis FD, van der Hoeven SM, Neto AS, Abreu MG, Pelosi P, Paulus F, Schultz MJ; for the NEBULAE; PReVENT; RELAx investigators. Effect of mechanical power on mortality in invasively ventilated ICU patients without the acute respiratory distress syndrome: An analysis of three randomised clinical trials. Eur J Anaesthesiol. 2023 Jan 1;40(1):21-28. doi: 10.1097/EJA.0000000000001778. Epub 2022 Nov 18.
Marcus J. Schultz, MD, PhD
Department of Intensive Care, Academic Medical Center
Frederique Paulus, PhD
Department of Intensive Care, Academic Medical Center
980 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2017
First Posted
May 30, 2017
Study Start
October 26, 2017
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Westfriesgasthuis
Hoorn, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Sint Antonius Hospital
Nieuwegein, Netherlands
Haaglanden Medical Center
The Hague, Netherlands
HagaZiekenhuis
The Hague, Netherlands
Isala Clinics
Zwolle, Netherlands
Writing Committee and Steering Committee for the RELAx Collaborative Group; Algera AG, Pisani L, Serpa Neto A, den Boer SS, Bosch FFH, Bruin K, Klooster PM, Van der Meer NJM, Nowitzky RO, Purmer IM, Slabbekoorn M, Spronk PE, van Vliet J, Weenink JJ, Gama de Abreu M, Pelosi P, Schultz MJ, Paulus F. Effect of a Lower vs Higher Positive End-Expiratory Pressure Strategy on Ventilator-Free Days in ICU Patients Without ARDS: A Randomized Clinical Trial. JAMA. 2020 Dec 22;324(24):2509-2520. doi: 10.1001/jama.2020.23517.
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, Moeniralam HS, Purmer I, Tuinman PR, Slabbekoorn M, Spronk PE, Vlaar APJ, Gama de Abreu M, Pelosi P, Serpa Neto A, Schultz MJ, Paulus F; RELAx Investigators and the PROVE Network Investigators. RELAx - REstricted versus Liberal positive end-expiratory pressure in patients without ARDS: protocol for a randomized controlled trial. Trials. 2018 May 9;19(1):272. doi: 10.1186/s13063-018-2640-5.
Primary Completion
January 14, 2020
Actual (reported)Study Completion
March 16, 2020
Actual (reported)Last Updated
March 31, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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