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

Completed

• Conditions: Mechanical Ventilation Complication; Pulmonary Complication; Surgery
• Interventions: Behavioral: High PEEP; Behavioral: Low PEEP

• Registration Number: NCT03937375
• Lead Sponsor: Hospital Israelita Albert Einstein

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2019-04
• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-30
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3837

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High PEEP	High PEEP	Use of high levels of PEEP with recruitment maneuvers
Low PEEP	Low PEEP	Use of low levels of PEEP without recruitment maneuvers

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative pulmonary complications	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

Name	Time	Method
Incidence of extrapulmonary pulmonary complications	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.
Incidence of intraoperative complications	Intraoperatively	Defined as intraoperative hypotension; or need for rescue for desaturations; or need for vasoactive drugs.
Incidence of severe postoperative pulmonary complications	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
Incidence of intensive care unit admission	Until hospital discharge, death or 100 days, whichever comes first	Incidence of intensive care unit admission during hospital stay
Hospital length of stay	Until hospital discharge, death or 100 days, whichever comes first	Duration of hospital length of stay in days
Incidence of 7-day mortality	Until day seven or hospital discharge, whichever comes first	Mortality during the first seven days of hospitalization
Incidence of in-hospital mortality	Until hospital discharge, death or 100 days, whichever comes first	Mortality during hospitalization
Incidence of major postoperative complications	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)

Trial Locations

Locations (3)

Amsterdam UMC, University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

University Hospital Carl Gustav Carus, Technische Universität Dresden; 🇩🇪 Dresden, Germany

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Spain