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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937375
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : February 4, 2021
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Hospital Carl Gustav Carus
Hospital Clínico Universitario de Valencia
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein

Study Description
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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.

Condition or disease Intervention/treatment
Surgery Mechanical Ventilation Complication Pulmonary Complication Behavioral: High PEEP Behavioral: Low PEEP

Study Design
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Study Type : Observational
Actual Enrollment : 3837 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : January 30, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of postoperative pulmonary complications [ Time Frame: Until day seven or hospital discharge, whichever comes first ]
    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.


Secondary Outcome Measures :
  1. Incidence of severe postoperative pulmonary complications [ Time Frame: Until day seven or hospital discharge, whichever comes first ]
    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

  2. Incidence of extrapulmonary pulmonary complications [ Time Frame: Until day seven or hospital discharge, whichever comes first ]
    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.

  3. Incidence of intraoperative complications [ Time Frame: Intraoperatively ]
    Defined as intraoperative hypotension; or need for rescue for desaturations; or need for vasoactive drugs.

  4. Incidence of intensive care unit admission [ Time Frame: Until hospital discharge, death or 100 days, whichever comes first ]
    Incidence of intensive care unit admission during hospital stay

  5. Hospital length of stay [ Time Frame: Until hospital discharge, death or 100 days, whichever comes first ]
    Duration of hospital length of stay in days

  6. Incidence of 7-day mortality [ Time Frame: Until day seven or hospital discharge, whichever comes first ]
    Mortality during the first seven days of hospitalization

  7. Incidence of in-hospital mortality [ Time Frame: Until hospital discharge, death or 100 days, whichever comes first ]
    Mortality during hospitalization

  8. Incidence of major postoperative complications [ Time Frame: Until day seven or hospital discharge, whichever comes first ]
    Collapsed composite of complications developing within the first seven postoperative combining severe postoperative pulmonary complications, sepsis, septic shock and/or acute kidney injury)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing mechanical ventilation for general anesthesia for surgery.
Criteria

Inclusion Criteria:

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937375


Locations
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Germany
University Hospital Carl Gustav Carus, Technische Universität Dresden
Dresden, Germany
Netherlands
Amsterdam UMC, University of Amsterdam
Amsterdam, Netherlands
Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Hospital Carl Gustav Carus
Hospital Clínico Universitario de Valencia
More Information
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Publications:
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.

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Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT03937375    
Other Study ID Numbers: REPEAT
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The harmonized dataset will be available after the publication of the main results and under request to the steering committee
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After the publication of the main results

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Israelita Albert Einstein:
Surgery
Mechanical ventilation
PEEP
Postoperative pulmonary complications
Individual patient data meta-analysis