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

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

Bluth, T. (författare): Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany.

Teichmann, R. (författare): Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany.

Kiss, T. (författare): Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany.

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Bobek, I. (författare): Semmelweis Egyet, Aneszteziol & Intenz Terapias Klin, Budapest, Hungary.

Canet, J. (författare): Hosp Badalona Germans Trias & Pujol, Dept Anesthesiol, Badalona, Spain.

Cinnella, G. (författare): Univ Foggia, Dept Anesthesiol & Intens Care Med, Foggia, Italy.

De Baerdemaeker, L. (författare): Univ Ghent, Dept Anesthesiol, Ghent, Belgium.

Gregoretti, C. (författare): Policlin P Giaccone, Dept Biopathol & Med Biotechnol, Palermo, Italy.

Hedenstierna, Göran, 1941- (författare): Uppsala universitet,Klinisk fysiologi

Hemmes, S. N. (författare): Univ Amsterdam, Acad Med Ctr, Dept Anesthesiol, Amsterdam, Netherlands.;Univ Amsterdam, Acad Med Ctr, LEICA, Amsterdam, Netherlands.

Hiesmayr, M. (författare): Med Univ Vienna, Div Cardiac Surg, Vienna, Austria.;Med Univ Vienna, Div Thorac Dis, Vienna, Austria.;Med Univ Vienna, Div Vasc Surg, Vienna, Austria.;Med Univ Vienna, Dept Anesthesia Intens Care & Pain Med, Vienna, Austria.

Hollmann, M. W. (författare): Univ Amsterdam, Acad Med Ctr, Dept Anesthesiol, Amsterdam, Netherlands.;Univ Amsterdam, Acad Med Ctr, LEICA, Amsterdam, Netherlands.

Jaber, S. (författare): St Eloi Univ Hosp, Dept Crit Care Med & Anesthesiol SAR B, Montpellier, France.

Laffey, J. G. (författare): St Michaels Hosp, Dept Anesthesia, Crit Care Med Program, Toronto, ON, Canada.;Univ Toronto, Dept Anesthesia, Toronto, ON, Canada.;Univ Toronto, Dept Physiol, Toronto, ON, Canada.;Univ Toronto, Interdepartmental Div Crit Care Med, Toronto, ON, Canada.

Licker, M. J. (författare): Univ Hosp Geneva, Dept Anesthesiol Pharmacol & Intens Care, Geneva, Switzerland.

Markstaller, K. (författare): Med Univ Vienna, Dept Anesthesia Intens Care & Pain Med, Vienna, Austria.

Matot, I. (författare): Tel Aviv Univ, Sackler Sch Med, Tel Aviv Med Ctr, Dept Anesthesia & Crit Care, Tel Aviv, Israel.

Mueller, G. (författare): Tech Univ Dresden, Ctr Evidence Based Healthcare, Univ Hosp, Dresden, Germany.;Tech Univ Dresden, Med Fac Carl Gustav Carus, Dresden, Germany.

Mills, G. H. (författare): Sheffield Teaching Hosp, OSCCA, Sheffield, S Yorkshire, England.;Univ Sheffield, Sheffield, S Yorkshire, England.

Mulier, J. P. (författare): AZ Sint Jan Brugge Oostende AV, Dept Anesthesiol, Brugge, Belgium.

Putensen, C. (författare): Univ Bonn, Dept Anesthesiol & Intens Care Med, Bonn, Germany.

Rossaint, R. (författare): Univ Aachen, Dept Anesthesiol, Aachen, Germany.

Schmitt, J. (författare): Tech Univ Dresden, Ctr Evidence Based Healthcare, Univ Hosp, Dresden, Germany.;Tech Univ Dresden, Med Fac Carl Gustav Carus, Dresden, Germany.

Senturk, M. (författare): Istanbul Univ, Istanbul Fac Med, Dept Anesthesiol & Intens Care Med, Istanbul, Turkey.

Serpa Neto, A. (författare): Fac Med ABC, Hosp Israelita Albert Einstein, Dept Crit Care Med, Sao Paulo, Brazil.;Fac Med ABC, Program Postgrad Res & Innovat, Sao Paulo, Brazil.

Severgnini, P. (författare): Univ Insubria, Dept Biotechnol & Sci Life, ASST Sette Laghi, Osped Cricolo & Fdn Macchi, Varese, Italy.

Sprung, J. (författare): Mayo Clin, Dept Anesthesiol, Rochester, MN USA.

Melo, M. F. Vidal (författare): Massachusetts Gen Hosp, Harvard Med Sch, Dept Anesthesia Crit Care & Pain Med, Boston, MA 02114 USA.

Wrigge, H. (författare): Univ Leipzig, Dept Anesthesiol & Intens Care Med, Leipzig, Germany.

Schultz, M. J. (författare): Univ Amsterdam, Acad Med Ctr, Dept Anesthesiol, Amsterdam, Netherlands.;Univ Amsterdam, Acad Med Ctr, LEICA, Amsterdam, Netherlands.

Pelosi, P. (författare): Univ Genoa, IRCCS AOU San Martino IST, Dept Surg Sci & Integrated Diagnost, Genoa, Italy.

de Abreu, M. Gama (författare): Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany.

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Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany Semmelweis Egyet, Aneszteziol & Intenz Terapias Klin, Budapest, Hungary. (creator_code:org_t)

2017-04-28
2017
Engelska.
Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 18

Relaterad länk:: https://doi.org/10.1...; visa fler...; https://uu.diva-port... (primary) (Raw object); https://uu.diva-port...; https://trialsjourna...; https://urn.kb.se/re...; https://doi.org/10.1...; visa färre...

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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/m(2) 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 cmH(2)O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH(2)O 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.

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Lungmedicin och ...

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

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