NCT03937375

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,837 (actual)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	High PEEP	Use of high levels of PEEP combined with recruitment maneuvers and low tidal volume ventilation during general anesthesia
BEHAVIORAL	Low PEEP	Use of low levels of PEEP without recruitment maneuvers and low tidal volume ventilation during general anesthesia

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-12-01
• Completion: 2020-01-30
• First posted: 2019-05-03
• Last updated: 2024-01-10

Locations

3 sites across 3 countries: Germany, Netherlands, Spain