AzTrials
AzTrials

SurgeryREPEATNCT03937375

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

An observational study of Surgery and Mechanical Ventilation Complication, run by Hospital Israelita Albert Einstein at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
High PEEP and Low PEEP
How many people
3,837 participants
Where
3 sitesin 3 countries
Study dates
1 Jan 2019to 30 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients undergoing mechanical ventilation for general anesthesia for surgery.

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Germany1 site

  • University Hospital Carl Gustav Carus, Technische Universität Dresden

    Dresden

Other trials in Germany

Netherlands1 site

  • Amsterdam UMC, University of Amsterdam

    Amsterdam

Other trials in Netherlands

Spain1 site

  • Hospital Clinico Universitario de Valencia

    Valencia

Other trials in Spain

About this study

Official title: Re-Evaluation of the Effects of High PEEP During General Anesthesia For Surgery - An Individual Patient Data Meta-Analysis of PROVHILO, iPROVE and PROBESE

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.

Being tested
High PEEP, Low PEEP
Keywords
Surgery, Mechanical ventilation, PEEP, Postoperative pulmonary complications, Individual patient data meta-analysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High PEEPBehavioural

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

  • Low PEEPBehavioural

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

Study groups in NCT03937375
Study groupRoleWhat they receive
High PEEPUse of high levels of PEEP with recruitment maneuvers
Receives: Behavioral: High PEEP
Low PEEPUse of low levels of PEEP without recruitment maneuvers
Receives: Behavioral: Low PEEP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Until day seven or hospital discharge, whichever comes first

Secondary outcomes (8)

  1. Incidence of severe postoperative pulmonary complications

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

    Measured: Until day seven or hospital discharge, whichever comes first

  2. Incidence of extrapulmonary pulmonary complications

    Collapsed composite of complications developing within the first seven postoperative days, including: Systemic Response Inflammatory Syndrome; or Sepsis; or Septic Shock; or Acute Kidney Injury.

    Measured: Until day seven or hospital discharge, whichever comes first

  3. Incidence of intraoperative complications

    Defined as intraoperative hypotension; or need for rescue for desaturations; or need for vasoactive drugs.

    Measured: Intraoperatively

  4. Incidence of intensive care unit admission

    Incidence of intensive care unit admission during hospital stay

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

  5. Hospital length of stay

    Duration of hospital length of stay in days

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

  6. Incidence of 7-day mortality

    Mortality during the first seven days of hospitalization

    Measured: Until day seven or hospital discharge, whichever comes first

  7. Incidence of in-hospital mortality

    Mortality during hospitalization

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

  8. Incidence of major postoperative complications

    Collapsed composite of complications developing within the first seven postoperative combining severe postoperative pulmonary complications, sepsis, septic shock and/or acute kidney injury)

    Measured: Until day seven or hospital discharge, whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2019
  2. Study start1 Jan 2019
  3. Primary completion1 Dec 2019
  4. Study completion30 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,837 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03937375
Sponsor's protocol ID
REPEAT
Acronym
REPEAT
Status last verified
Apr 2019
First submitted
2 May 2019
Last updated
10 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The harmonized dataset will be available after the publication of the main results and under request to the steering committee

Publications

  • 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.

    PubMed 21548927

  • 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.

    PubMed 24894577

  • 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.

    PubMed 25927183

  • 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.

    PubMed 29371130

  • 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.

    PubMed 28454590

  • 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.

    PubMed 39698861

  • 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.

    PubMed 37234075

  • 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.

    PubMed 35431038

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and Mechanical Ventilation Complication, run by Hospital Israelita Albert Einstein at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperative pulmonary complications (time frame: Until day seven or hospital discharge, whichever comes first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03937375, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in