Re-Evaluation of the Effects of High PEEP During General Anesthesia For Surgery (REPEAT)

NCT03937375 | Completed

• 1 other identifier: REPEAT
• Study Type: observational
• Target: 3,837
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Surgery; Mechanical Ventilation Complication; Pulmonary Complication

Keywords

Surgery; Mechanical ventilation; PEEP; Postoperative pulmonary complications; Individual patient data meta-analysis

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative pulmonary complications

  Collapsed composite of complications developing within the first seven postoperative days, including: Mild respiratory failure; or Severe respiratory failure; or Acute Respiratory Distress Syndrome (ARDS); or Pulmonary infection; or Pleural effusion; or Atelectasis; or Pneumothorax; or Bronchospasm.

  Until day seven or hospital discharge, whichever comes first

Secondary Outcomes (8)

• Incidence of severe postoperative pulmonary complications

  Until day seven or hospital discharge, whichever comes first

• Incidence of extrapulmonary pulmonary complications

  Until day seven or hospital discharge, whichever comes first

• Incidence of intraoperative complications

  Intraoperatively

• Incidence of intensive care unit admission

  Until hospital discharge, death or 100 days, whichever comes first

• Hospital length of stay

  Until hospital discharge, death or 100 days, whichever comes first

Study Arms (2)

High PEEP

Use of high levels of PEEP with recruitment maneuvers

Behavioral: High PEEP

Low PEEP

Use of low levels of PEEP without recruitment maneuvers

Behavioral: Low PEEP

Interventions

High PEEP BEHAVIORAL

Use of high levels of PEEP combined with recruitment maneuvers and low tidal volume ventilation during general anesthesia

High PEEP

Low PEEP BEHAVIORAL

Use of low levels of PEEP without recruitment maneuvers and low tidal volume ventilation during general anesthesia

Low PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing mechanical ventilation for general anesthesia for surgery.

You may qualify if:

• \- Enrolled into one of the three studies (PROVHILO, iPROVE or PROBESE) to either high PEEP or low PEEP

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• University Hospital Carl Gustav Carus: collaborator
• Hospital Clínico Universitario de Valencia: collaborator

Study Sites (3)

University Hospital Carl Gustav Carus, Technische Universität Dresden

Dresden, Germany

Location

Amsterdam UMC, University of Amsterdam

Amsterdam, Netherlands

Location

Hospital Clinico Universitario de Valencia

Valencia, Spain

Location

Related Publications (8)

• 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.

  PMID: 21548927 BACKGROUND

• 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.

  PMID: 24894577 BACKGROUND

• Ferrando C, Soro M, Canet J, Unzueta MC, Suarez F, Librero J, Peiro S, Llombart A, Delgado C, Leon I, Rovira L, Ramasco F, Granell M, Aldecoa C, Diaz O, Balust J, Garutti I, de la Matta M, Pensado A, Gonzalez R, Duran ME, Gallego L, Del Valle SG, Redondo FJ, Diaz P, Pestana D, Rodriguez A, Aguirre J, Garcia JM, Garcia J, Espinosa E, Charco P, Navarro J, Rodriguez 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.

  PMID: 25927183 BACKGROUND

• Ferrando C, Soro M, Unzueta C, Suarez-Sipmann F, Canet J, Librero J, Pozo N, Peiro S, Llombart A, Leon I, India I, Aldecoa C, Diaz-Cambronero O, Pestana D, Redondo FJ, Garutti I, Balust J, Garcia JI, Ibanez M, Granell M, Rodriguez A, Gallego L, de la Matta M, Gonzalez R, Brunelli A, Garcia J, Rovira L, Barrios F, Torres V, Hernandez S, Gracia E, Gine M, Garcia M, Garcia N, Miguel L, Sanchez S, Pineiro P, Pujol R, Garcia-Del-Valle S, Valdivia J, Hernandez MJ, Padron O, Colas 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.

  PMID: 29371130 BACKGROUND

• 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, Muller 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.

  PMID: 28454590 BACKGROUND

• Serpa Neto A, Campos NS, Bluth T, Hemmes SNT, Ferrando C, Librero J, Soro M, Ball L, Mazzinari G, de Abreu MG, Schultz MJ; for REPEAT on behalf of the PROVHILO , iPROVE and PROBESE Investigators, and the PROVE Network investigators. Win Ratio approach for the composite outcome of postoperative pulmonary complications: Secondary analysis of a harmonised and pooled database of three randomised clinical trials. Eur J Anaesthesiol. 2025 Apr 1;42(4):340-346. doi: 10.1097/EJA.0000000000002116. Epub 2024 Dec 18.

  PMID: 39698861 DERIVED

• Mazzinari G, Zampieri FG, Ball L, Campos NS, Bluth T, Hemmes SNT, Ferrando C, Librero J, Soro M, Pelosi P, Gama de Abreu M, Schultz MJ, Serpa Neto A; PROVHILO investigators; iPROVE investigators; PROBESE investigators; PROVE network investigators. Effect of intraoperative PEEP with recruitment maneuvers on the occurrence of postoperative pulmonary complications during general anesthesia--protocol for Bayesian analysis of three randomized clinical trials of intraoperative ventilation. F1000Res. 2023 Jun 23;11:1090. doi: 10.12688/f1000research.125861.2. eCollection 2022.

  PMID: 37234075 DERIVED

• Campos NS, Bluth T, Hemmes SNT, Librero J, Pozo N, Ferrando C, Ball L, Mazzinari G, Pelosi P, Gama de Abreu M, Schultz MJ, Serpa Neto A; REPEAT; investigators for the PROVHILO study; iPROVE study; PROBESE study investigators; PROVE Network. Intraoperative positive end-expiratory pressure and postoperative pulmonary complications: a patient-level meta-analysis of three randomised clinical trials. Br J Anaesth. 2022 Jun;128(6):1040-1051. doi: 10.1016/j.bja.2022.02.039. Epub 2022 Apr 15.

  PMID: 35431038 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 3, 2019
• Study Start: January 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 30, 2020
• Last Updated: January 10, 2024

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After the publication of the main results

Locations

ES (1); DE (1); NL (1)