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

PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)

doi:10.1186/s13063-017-1929-0

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

PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)

University Hospital Carl Gustav Carus
Semmelweis University
Hospital Universitari Germans Trias i Pujol
Medical University Vienna
University of Foggia
Ghent University Hospital
University Hospital Basel
Department of Biopathology and Medical Biotechnologies
University Hospital Uppsala
University of Amsterdam
Saint Eloi University Hospital
St. Michael's Hospital, Toronto
University of Toronto
University of Toronto Faculty of Medicine
Zaporozhye State Medical University
Geneva University Hospitals
University of Insubria
Tel Aviv University
Ponderas Hospital
Faculty of Medicine of the TU Dresden
Sheffield Teaching Hospitals NHS Foundation Trust
Lutsk Clinical Hospital
Clinical Hospital Dubrava
University of Bonn
University Hospital Aachen
University of Istanbul
Hospital Israelita Albert Einstein
Faculdade de Medicina do ABC
Fatih Sultan Mehmet Educational and Research Hospital
Mayo Clinic
Montefiore Medical Center
Massachusetts General Hospital
University of Leipzig
IRCCS for Oncology and Neurosciences
Universitätsklinikum Düsseldorf
Medical Center of the Johannes Gutenberg University
University Clinic Knappschaftskrankenhaus Bochum
Ruprecht-Karls-University Heidelberg
University Clinic of Surgery St. Naum Ohridski
Marienhospital Wesel
University Hospital Bonn
Centro Hospitalar e Universitário do Porto
Centro Hospitalar Entre o Douro e Vouga
São João University Hospital Centre
Hospital Pedro Hispano de Matosinhos
Mayo Clinic in Jacksonville, Florida
Mayo Clinic Scottsdale-Phoenix, Arizona
University of Colorado Anschutz Medical Campus
Tufts Medical Center
University of Mississippi
University of Chicago
Pontificia Universidad Católica de Chile
Leiden University Medical Center
Department of Anesthesiology
VU University Medical Center
Onze Lieve Vrouwe Gasthuis
Hospital Clinico Universitario de Valencia
Consorcio Hospital General Universitario de Valencia
La Paz University Hospital
Hospital Universitari Mútua de Terrassa
Hospital Clínic
King Abdullah Medical City
Assiut University
Mansoura Faculty of Medicine
Alexandra Hospital
King Abdul-Aziz Cardiac Center
Dokuz Eylül University
Marmara University School of Medicine
Akdeniz University Hospital
Azienda Ospedaliera Universitaria di Ferrara
Second University of Naples
Ospedale U. Parini
Kantonsspital Frauenfeld
University Hospital “Sveti Duh” Zagreb
UH Antwerpen
KU Leuven– University Hospital Leuven
AZ Sint Jan Brugge
Clinique Universitaires de Saint-Luc
St James's Hospital
University Hospital of Ostrava
Tel Aviv Medical Center
Barlicki University Hospital
North Staffs Hospital NHS Trust
Ashford and St Peter Hospitals NHS Trust
Royal Cornwall Hospital
Hull University Teaching Hospitals NHS Trust
Imperial College Healthcare NHS Trust
Brighton and Sussex University Hospitals
York Teaching Hospital
Homerton University Hospitals NHS Foundation Trust
Southmead Hospital NHS Foundation Trust

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

50 Citations (Scopus)

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.

Original language	English
Article number	202
Journal	Trials
Volume	18
Issue number	1
DOIs	https://doi.org/10.1186/s13063-017-1929-0
Publication status	Published - 28 Apr 2017
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Mechanical ventilation
Obesity
Positive end-expiratory pressure
Postoperative pulmonary complication
Recruitment maneuver

Access to Document

10.1186/s13063-017-1929-0

Cite this

PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA) (2017). Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): Study protocol for a randomized controlled trial. Trials, 18(1), Article 202. https://doi.org/10.1186/s13063-017-1929-0

PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA). / Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE) : Study protocol for a randomized controlled trial. In: Trials. 2017 ; Vol. 18, No. 1.

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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",

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.",

keywords = "Mechanical ventilation, Obesity, Positive end-expiratory pressure, Postoperative pulmonary complication, Recruitment maneuver",

author = "\{PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)\} and T. Bluth and R. Teichmann and T. Kiss and I. Bobek and J. Canet and G. Cinnella and \{De Baerdemaeker\}, L. and C. Gregoretti and G. Hedenstierna and Hemmes, \{S. N.\} and M. Hiesmayr and Hollmann, \{M. W.\} and S. Jaber and Laffey, \{J. G.\} and Licker, \{M. J.\} and K. Markstaller and I. Matot and G. M{\"u}ller and Mills, \{G. H.\} and Mulier, \{J. P.\} and C. Putensen and R. Rossaint and J. Schmitt and M. Senturk and \{Serpa Neto\}, A. and P. Severgnini and J. Sprung and \{Vidal Melo\}, \{M. F.\} and H. Wrigge and Schultz, \{M. J.\} and P. Pelosi and \{Gama de Abreu\}, M. and Andreas G{\"u}ldner and Robert Huhle and Christopher Uhlig and Luigi Vivona and Alice Bergamaschi and Ana Stevanovic and Tanja Treschan and Maximilian Schaefer and Peter Kienbaum and Rita Laufenberg-Feldmann and Lars Bergmann and Felix Ebner and Luisa Robitzky and Patrick M{\"o}lders and Matthias Unterberg and Cornelius Busch and Marc Achilles and Angelika Menzen and Harbert Freesemann and Humberto Machado and Carla Cavaleiro and Ferreira, \{Cristina P.\} and Daniela Pinho and Marta Carvalho and S{\'i}lvia Pinho and Maria Soares and Castro, \{Diogo Sousa\} and Fernando Abelha and Rui Rabico and Ellise Delphin and Weingarten, \{Toby N.\} and Kellogg, \{Todd A.\} and Martin, \{Yvette N.\} and McKenzie, \{Travis J.\} and Brull, \{Sorin J.\} and Renew, \{J. Ross\} and Harish Ramakrishna and Ana Fernandez-Bustamante and Konstantin Balonov and Baig, \{Harris R.\} and Aalok Kacha and Pedemonte, \{Juan C.\} and Fernando Altermatt and Corvetto, \{Marcia A.\} and Sebastian Paredes and Javiera Carmona and Augusto Rolle and Elke Bos and Charlotte Beurskens and B. Veering and Harry Zonneveldt and Christa Boer and Marc Godfried and Bram Thiel and Barbara Kabon and Christian Reiterer and Raquel Tol{\'o}s and Mar Sendra and Miriam Gonz{\'a}lez and Noem{\'i} G{\'o}mez and Carlos Ferrando and Tania Socorro and Ana Izquierdo and Marina Soro and \{Granell Gil\}, Manuel and \{Hern{\'a}ndez C{\'a}diz\}, \{Mar{\'i}a Jos{\'e}\} and \{Biosca P{\'e}rez\}, Elena and Alejandro Suarez-de-la-Rica",

note = "Publisher Copyright: {\textcopyright} 2017 The Author(s).",

year = "2017",

month = apr,

day = "28",

doi = "10.1186/s13063-017-1929-0",

language = "English",

volume = "18",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd",

number = "1",

}

PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA) 2017, 'Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): Study protocol for a randomized controlled trial', Trials, vol. 18, no. 1, 202. https://doi.org/10.1186/s13063-017-1929-0

Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): Study protocol for a randomized controlled trial. / PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA).
In: Trials, Vol. 18, No. 1, 202, 28.04.2017.

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

TY - JOUR

T1 - Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE)

T2 - Study protocol for a randomized controlled trial

AU - PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)

AU - Bluth, T.

AU - Teichmann, R.

AU - Kiss, T.

AU - Bobek, I.

AU - Canet, J.

AU - Cinnella, G.

AU - De Baerdemaeker, L.

AU - Gregoretti, C.

AU - Hedenstierna, G.

AU - Hemmes, S. N.

AU - Hiesmayr, M.

AU - Hollmann, M. W.

AU - Jaber, S.

AU - Laffey, J. G.

AU - Licker, M. J.

AU - Markstaller, K.

AU - Matot, I.

AU - Müller, G.

AU - Mills, G. H.

AU - Mulier, J. P.

AU - Putensen, C.

AU - Rossaint, R.

AU - Schmitt, J.

AU - Senturk, M.

AU - Serpa Neto, A.

AU - Severgnini, P.

AU - Sprung, J.

AU - Vidal Melo, M. F.

AU - Wrigge, H.

AU - Schultz, M. J.

AU - Pelosi, P.

AU - Gama de Abreu, M.

AU - Güldner, Andreas

AU - Huhle, Robert

AU - Uhlig, Christopher

AU - Vivona, Luigi

AU - Bergamaschi, Alice

AU - Stevanovic, Ana

AU - Treschan, Tanja

AU - Schaefer, Maximilian

AU - Kienbaum, Peter

AU - Laufenberg-Feldmann, Rita

AU - Bergmann, Lars

AU - Ebner, Felix

AU - Robitzky, Luisa

AU - Mölders, Patrick

AU - Unterberg, Matthias

AU - Busch, Cornelius

AU - Achilles, Marc

AU - Menzen, Angelika

AU - Freesemann, Harbert

AU - Machado, Humberto

AU - Cavaleiro, Carla

AU - Ferreira, Cristina P.

AU - Pinho, Daniela

AU - Carvalho, Marta

AU - Pinho, Sílvia

AU - Soares, Maria

AU - Castro, Diogo Sousa

AU - Abelha, Fernando

AU - Rabico, Rui

AU - Delphin, Ellise

AU - Weingarten, Toby N.

AU - Kellogg, Todd A.

AU - Martin, Yvette N.

AU - McKenzie, Travis J.

AU - Brull, Sorin J.

AU - Renew, J. Ross

AU - Ramakrishna, Harish

AU - Fernandez-Bustamante, Ana

AU - Balonov, Konstantin

AU - Baig, Harris R.

AU - Kacha, Aalok

AU - Pedemonte, Juan C.

AU - Altermatt, Fernando

AU - Corvetto, Marcia A.

AU - Paredes, Sebastian

AU - Carmona, Javiera

AU - Rolle, Augusto

AU - Bos, Elke

AU - Beurskens, Charlotte

AU - Veering, B.

AU - Zonneveldt, Harry

AU - Boer, Christa

AU - Godfried, Marc

AU - Thiel, Bram

AU - Kabon, Barbara

AU - Reiterer, Christian

AU - Tolós, Raquel

AU - Sendra, Mar

AU - González, Miriam

AU - Gómez, Noemí

AU - Ferrando, Carlos

AU - Socorro, Tania

AU - Izquierdo, Ana

AU - Soro, Marina

AU - Granell Gil, Manuel

AU - Hernández Cádiz, María José

AU - Biosca Pérez, Elena

AU - Suarez-de-la-Rica, Alejandro

PY - 2017/4/28

Y1 - 2017/4/28

N2 - 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.

AB - 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.

KW - Mechanical ventilation

KW - Obesity

KW - Positive end-expiratory pressure

KW - Postoperative pulmonary complication

KW - Recruitment maneuver

UR - https://www.scopus.com/pages/publications/85018239566

U2 - 10.1186/s13063-017-1929-0

DO - 10.1186/s13063-017-1929-0

M3 - Article

C2 - 28454590

AN - SCOPUS:85018239566

SN - 1745-6215

VL - 18

JO - Trials

JF - Trials

IS - 1

M1 - 202

ER -

PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA). Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): Study protocol for a randomized controlled trial. Trials. 2017 Apr 28;18(1):202. doi: 10.1186/s13063-017-1929-0

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

Abstract

UN SDGs

Keywords

Access to Document

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