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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.

Collaborators (157)

Güldner A, Huhle R, Uhlig C, Vivona L, Bergamaschi A, Rossaint R, Stevanovic A, Treschan T, Schaefer M, Kienbaum P, Laufenberg-Feldmann R, Bergmann L, Ebner F, Robitzky L, Mölders P, Unterberg M, Busch C, Achilles M, Menzen A, Freesemann H, Putensen C, Machado H, Cavaleiro C, Ferreira C, Pinho D, Carvalho M, Pinho S, Soares M, Castro DS, Abelha F, Rabico R, Delphin E, Sprung J, Weingarten TN, Kellogg TA, Martin YN, McKenzie TJ, Brull SJ, Renew JR, Ramakrishna H, Fernandez-Bustamante A, Balonov K, Baig HR, Kacha A, Pedemonte JC, Altermatt F, Corvetto MA, Paredes S, Carmona J, Rolle A, Bos E, Beurskens C, Veering B, Zonneveldt H, Boer C, Godfried M, Thiel B, Kabon B, Reiterer C, Canet J, Tolós R, Sendra M, González M, Gómez N, Ferrando C, Socorro T, Izquierdo A, Soro M, Granell Gil M, Hernández Cádiz MJ, Biosca Pérez E, Suarez-de-la-Rica A, Lopez-Martinez M, Huercio I, Maseda E, Yagüe J, Cebrian Moreno A, Rivas E, Lopez-Baamonde M, Elgendy H, Sayedalahl M, SIibai AR, Yavru A, Sivrikoz N, Karadeniz M, Corman Dincer P, Ayanoglu HO, Tore Altun G, Kavas AD, Dinc B, Kuvaki B, Ozbilgin S, Erdogan D, Koksal C, Abitagaglu S, Aurilio C, Sansone P, Pace CM, Donatiello V, Mattera S, Nazareno P, Di Colandrea S, Spadaro S, Volta CA, Ragazzi R, Ciardo S, Gobbi L, Severgnini P, Bacuzzi A, Brugnoni E, Gratarola A, Micalizzi C, Simonassi F, Malerbi P, Carboni A, Licker MJ, Dullenkopf A, Goettel N, Nesek Adam V, Karaman Ilić M, Klaric V, Vitkovic B, Milic M, Zupcic M, De Baerdemaeker L, De Hert S, Heyse B, Van Limmen J, Van Nieuwenhove Y, Mertens E, Neyrinck A, Mulier J, Kahn D, Godoroja D, Martin-Loeches M, Vorotyntsev S, Fronchko V, Matot I, Goren O, Zac L, Gaszynski T, Laffey J, Mills G, Nalwaya P, Mac Gregor M, Paddle J, Balaji P, Rubulotta F, Adebesin A, Margarson M, Davies S, Rangarajan D, Newell C, Shosholcheva M, Papaspyros F, Skandalou V, Dzurňáková P.

Author information

1
Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Dresden, Germany.
2
Aneszteziológiai és Intenzív Terápiás Klinika, Semmelweis Egyetem, Budapest, Hungary.
3
Department of Anesthesiology, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
4
Department of Anesthesiology and Intensive Care Medicine, University of Foggia, Foggia, Italy.
5
Department of Anesthesiology, Ghent University Hospital, Ghent, Belgium.
6
Department of Biopathology and Medical Biotechnologies, Policlinico "P. Giaccone", Palermo, Italy.
7
Section of Clinical Physiology, Department of Medical Sciences, University Hospital, Uppsala, Sweden.
8
Department of Anesthesiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
9
Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
10
Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
11
Division of Thoracic Surgery, Medical University of Vienna, Vienna, Austria.
12
Division of Vascular Surgery, Medical University of Vienna, Vienna, Austria.
13
Department of Anesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.
14
Department of Critical Care Medicine and Anesthesiology (SAR B), Saint Eloi University Hospital, Montpellier, France.
15
Critical Care Medicine Program, Department of Anesthesia, Saint Michael's Hospital, Toronto, ON, Canada.
16
Department of Anesthesia, University of Toronto, Toronto, ON, Canada.
17
Department of Physiology, University of Toronto, Toronto, ON, Canada.
18
Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
19
Department of Anesthesiology, Pharmacology and Intensive Care, University Hospital Geneva, Geneva, Switzerland.
20
Department of Anesthesiology and Critical Care, Tel Aviv Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
21
Center for Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, Technical University Dresden, Dresden, Germany.
22
Operating Services, Critical Care and Anaesthesia (OSCCA), Sheffield Teaching Hospitals and University of Sheffield, Sheffield, UK.
23
Department of Anesthesiology, AZ Sint Jan Brugge-Oostende AV, Brugge, Belgium.
24
Department of Anesthesiology and Intensive Care Medicine, University of Bonn, Bonn, Germany.
25
Department of Anesthesiology, University of Aachen, Aachen, Germany.
26
Department of Anesthesiology and Intensive Care Medicine, Istanbul Medical Faculty, University of Istanbul, Istanbul, Turkey.
27
Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Faculdade de Medicina do ABC, São Paulo, Brazil.
28
Program of Post-Graduation, Research and Innovation, Faculdade de Medicina do ABC, São Paulo, Brazil.
29
Department of Biotechnology and Sciences of Life, University of Insubria, ASST dei Sette Laghi, Ospedale di Cricolo e Fondazione Macchi, Varese, Italy.
30
Department of Anesthesiology, Mayo Clinic, Rochester, MN, USA.
31
Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
32
Department of Anesthesiology and Intensive Care Medicine, University of Leipzig, Leipzig, Germany.
33
Department of Intensive Care, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
34
Department of Surgical Sciences and Integrated Diagnostics, IRCCS AOU San Martino - IST, University of Genoa, Genoa, Italy.
35
Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Dresden, Germany. mgabreu@uniklinikum-dresden.de.

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

PMID:
28454590
PMCID:
PMC5410049
DOI:
10.1186/s13063-017-1929-0
[Indexed for MEDLINE]
Free PMC Article

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