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Completed

NCT Number: NCT03937375

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

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.

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Key information

Conditions

Surgery Mechanical Ventilation Complication Pulmonary Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

High PEEP

Behavioral

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

Low PEEP

Behavioral

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Hospital Clínico Universitario de Valencia
  • University Hospital Carl Gustav Carus

Registry information

Official study 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

Acronym: REPEAT

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 3, 2019
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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