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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

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

Clinicaltrials.gov identifier NCT03937375

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted May 31, 2019

Study Description

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:Surgery
    Mechanical Ventilation Complication
    Pulmonary Complication
  • Intervention/Treatment: Behavioral: High PEEP
    Behavioral: Low PEEP
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated 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 2019
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: July 2020
Groups and Cohorts
Groups/Cohorts 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
  • 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
  • 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
Contacts

Contact: Ary Serpa Neto, MD, MSc, PhD +55 11 2151 1521 ary.neto2@einstein.br

Contact: Niklas S Campos, MD +55 11 2151 1521 niklas.soderberg@einstein.br

Locations

Germany
University Hospital Carl Gustav Carus, Technische Universität Dresden
Dresden

Netherlands
Amsterdam UMC, University of Amsterdam
Amsterdam

Spain
Hospital Clinico Universitario de Valencia
Valencia

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