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Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03937375
Recruitment Status Recruiting
First Posted May 3, 2019
Last update posted May 31, 2019
Aiming to understand the isolated impact of high PEEP in patients undergoing mechanical ventilation for general anesthesia for surgery, three appropriately sized international multicentre randomized controlled trials have been performed over recent years: the 'PROtective Ventilation using HIgh versus LOw PEEP trial (PROVHILO), the 'individualized PeRioperative Open-lung Ventilation trial' (iPROVE), and the 'Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients trial' (PROBESE). These three trials had several similarities in key areas of their study protocols, inclusion and exclusion criteria, and collected data, and even the primary and secondary outcomes. Of note, the three trials combined high PEEP with recruitment manoeuvres. This allows an individual patient data meta-analysis.
|: High PEEP
Use of high levels of PEEP with recruitment maneuvers
Behavioral: High PEEP
Use of high levels of PEEP combined with recruitment maneuvers and low tidal volume ventilation during general anesthesia
|: Low PEEP
Use of low levels of PEEP without recruitment maneuvers
Behavioral: Low PEEP
Use of low levels of PEEP without recruitment maneuvers and low tidal volume ventilation during general anesthesia
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Enrolled into one of the three studies (PROVHILO, iPROVE or PROBESE) to either high PEEP
or low PEEP
Contact: Ary Serpa Neto, MD, MSc, PhD +55 11 2151 1521 firstname.lastname@example.org
Contact: Niklas S Campos, MD +55 11 2151 1521 email@example.com
University Hospital Carl Gustav Carus, Technische Universität Dresden
Amsterdam UMC, University of Amsterdam
Hospital Clinico Universitario de Valencia
Hospital Israelita Albert Einstein
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Hospital Carl Gustav Carus
Hospital Clínico Universitario de Valencia
Hemmes SN, Severgnini P, Jaber S, Canet J, Wrigge H, Hiesmayr M, Tschernko EM, Hollmann MW, Binnekade JM, Hedenstierna G, Putensen C, de Abreu MG, Pelosi P, Schultz MJ. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery. Trials. 2011 May 6;12:111. doi: 10.1186/1745-6215-12-111.
PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology, Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.
Ferrando C, Soro M, Canet J, Unzueta MC, Suárez F, Librero J, Peiró S, Llombart A, Delgado C, León I, Rovira L, Ramasco F, Granell M, Aldecoa C, Diaz O, Balust J, Garutti I, de la Matta M, Pensado A, Gonzalez R, Durán ME, Gallego L, Del Valle SG, Redondo FJ, Diaz P, Pestaña D, Rodríguez A, Aguirre J, García JM, García J, Espinosa E, Charco P, Navarro J, Rodríguez C, Tusman G, Belda FJ; iPROVE investigators (Appendices 1 and 2). Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial. Trials. 2015 Apr 27;16:193. doi: 10.1186/s13063-015-0694-1.
Ferrando C, Soro M, Unzueta C, Suarez-Sipmann F, Canet J, Librero J, Pozo N, Peiró S, Llombart A, León I, India I, Aldecoa C, Díaz-Cambronero O, Pestaña D, Redondo FJ, Garutti I, Balust J, García JI, Ibáñez M, Granell M, Rodríguez A, Gallego L, de la Matta M, Gonzalez R, Brunelli A, García J, Rovira L, Barrios F, Torres V, Hernández S, Gracia E, Giné M, García M, García N, Miguel L, Sánchez S, Piñeiro P, Pujol R, García-Del-Valle S, Valdivia J, Hernández MJ, Padrón O, Colás A, Puig J, Azparren G, Tusman G, Villar J, Belda J; Individualized PeRioperative Open-lung VEntilation (iPROVE) Network. Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial. Lancet Respir Med. 2018 Mar;6(3):193-203. doi: 10.1016/S2213-2600(18)30024-9. Epub 2018 Jan 19.
Bluth T, Teichmann R, Kiss T, Bobek I, Canet J, Cinnella G, De Baerdemaeker L, Gregoretti C, Hedenstierna G, Hemmes SN, Hiesmayr M, Hollmann MW, Jaber S, Laffey JG, Licker MJ, Markstaller K, Matot I, Müller G, Mills GH, Mulier JP, Putensen C, Rossaint R, Schmitt J, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE investigators; PROtective VEntilation Network (PROVEnet); 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. Erratum in: Trials. 2017 Jun 1;18(1):247.