REstricted Versus Liberal Positive End-Expiratory Pressure in Patients Without ARDS

Summary

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.

Conditions

• Ventilator-free Days

Interventions

PROCEDURE

restricted PEEP

Patients are randomized and ventilated with restricted PEEP (the lowest possible PEEP level, 0 - 5 cm H2O)

PROCEDURE

liberal PEEP

Patients are randomized and ventilated with liberal PEEP (the median PEEP level used in the Netherlands, 8 cm H2O)

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Amphia Hospital

  collaborator OTHER

• Gelre Hospitals

  collaborator OTHER

• Isala

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Medical Center Haaglanden

  collaborator OTHER

• Onze Lieve Vrouwe Gasthuis

  collaborator OTHER

• St. Antonius Hospital

  collaborator OTHER

• Amsterdam UMC, location VUmc

  collaborator OTHER

• Dijklander Ziekenhuis

  collaborator OTHER

• Spaarne Gasthuis

  collaborator OTHER

• HagaZiekenhuis

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Principal Investigators

• Marcus J. Schultz, MD, PhD · Department of Intensive Care, Academic Medical Center

• Frederique Paulus, PhD · Department of Intensive Care, Academic Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-26

Primary Completion

2020-01-14

Completion

2020-03-16

Countries

• Netherlands

Study Locations