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

Issued Date

2018-05-09

Resource Type

Article

ISSN

17456215

DOI

10.1186/s13063-018-2640-5

Other identifier(s)

2-s2.0-85046693906

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

Trials. Vol.19, No.1 (2018)

Suggested Citation

Anna Geke Algera, Luigi Pisani, Dennis C.J. Bergmans, Sylvia den Boer, Corianne A.J. de Borgie, Frank H. Bosch, Karina Bruin, Thomas G. Cherpanath, Rogier M. Determann, Arjen M. Dondorp, Dave A. Dongelmans, Henrik Endeman, Jasper J. Haringman, Janneke Horn, Nicole P. Juffermans, David M. van Meenen, Nardo J. van der Meer, Maruschka P. Merkus, Hazra S. Moeniralam, Ilse Purmer, Pieter Roel Tuinman, Mathilde Slabbekoorn, Peter E. Spronk, Alexander P.J. Vlaar, Marcelo Gama de Abreu, Paolo Pelosi, Ary Serpa Neto, Marcus J. Schultz, Frederique Paulus RELAx - REstricted versus Liberal positive end-expiratory pressure in patients without ARDS: Protocol for a randomized controlled trial. Trials. Vol.19, No.1 (2018). doi:10.1186/s13063-018-2640-5 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/46669

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Title

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

Author(s)

Anna Geke Algera
 Luigi Pisani
 Dennis C.J. Bergmans
 Sylvia den Boer
 Corianne A.J. de Borgie
 Frank H. Bosch
 Karina Bruin
 Thomas G. Cherpanath
 Rogier M. Determann
 Arjen M. Dondorp
 Dave A. Dongelmans
 Henrik Endeman
 Jasper J. Haringman
 Janneke Horn
 Nicole P. Juffermans
 David M. van Meenen
 Nardo J. van der Meer
 Maruschka P. Merkus
 Hazra S. Moeniralam
 Ilse Purmer
 Pieter Roel Tuinman
 Mathilde Slabbekoorn
 Peter E. Spronk
 Alexander P.J. Vlaar
 Marcelo Gama de Abreu
 Paolo Pelosi
 Ary Serpa Neto
 Marcus J. Schultz
 Frederique Paulus

Other Contributor(s)

Ospedale Policlinico San Martino
 Gelre Ziekenhuizen
 Amphia Hospital
 HagaZiekenhuis
 St. Antonius Ziekenhuis
 Dresden University Faculty of Medicine and University Hospital Carl Gustav Carus
 Our Lady Hospital - Amsterdam
 Hospital Israelita Albert Einstein
 Mahidol University
 University Hospital Maastricht
 Isala Clinics
 Amsterdam UMC - Vrije Universiteit Amsterdam
 Amsterdam UMC - University of Amsterdam
 Spaarne Gasthuis
 Rijnstate
 Haaglanden Medical Center

Abstract

© 2018 The Author(s). 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 H 2 O, while patients assigned to ventilation with high PEEP will receive PEEP of 8 cm H 2 O. 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.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/46669

Collections

Scopus 2018