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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial

Authors: T. Bluth, R. Teichmann, T. Kiss, I. Bobek, J. Canet, G. Cinnella, L. De Baerdemaeker, C. Gregoretti, G. Hedenstierna, S. N. Hemmes, M. Hiesmayr, M. W. Hollmann, S. Jaber, J. G. Laffey, M. J. Licker, K. Markstaller, I. Matot, G. Müller, G. H. Mills, J. P. Mulier, C. Putensen, R. Rossaint, J. Schmitt, M. Senturk, A. Serpa Neto, P. Severgnini, J. Sprung, M. F. Vidal Melo, H. Wrigge, M. J. Schultz, P. Pelosi, M. Gama de Abreu, for the PROBESE investigators, and the PROtective VEntilation Network (PROVEnet), on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)

Published in: Trials | Issue 1/2017

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Abstract

Background

Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients.

Methods/design

The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH2O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH2O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint.

Discussion

To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs.

Trial registration

ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.
Appendix
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Metadata
Title
Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial
Authors
T. Bluth
R. Teichmann
T. Kiss
I. Bobek
J. Canet
G. Cinnella
L. De Baerdemaeker
C. Gregoretti
G. Hedenstierna
S. N. Hemmes
M. Hiesmayr
M. W. Hollmann
S. Jaber
J. G. Laffey
M. J. Licker
K. Markstaller
I. Matot
G. Müller
G. H. Mills
J. P. Mulier
C. Putensen
R. Rossaint
J. Schmitt
M. Senturk
A. Serpa Neto
P. Severgnini
J. Sprung
M. F. Vidal Melo
H. Wrigge
M. J. Schultz
P. Pelosi
M. Gama de Abreu
for the PROBESE investigators
and the PROtective VEntilation Network (PROVEnet)
on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1929-0

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