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

Surgery Clinical Trial

— REPEAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937375
• Other study ID #: REPEAT
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: April 2019
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3837
• Est. completion date: January 30, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Pulmonary Complication
• Surgery

Intervention

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 and low tidal volume ventilation during general anesthesia

Locations

Country	Name	City	State
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 (4)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Hospital Clínico Universitario de Valencia, University Hospital Carl Gustav Carus

Countries where clinical trial is conducted

Germany,  Netherlands,  Spain, 

References & Publications (5)

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, Muller 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. — View Citation

Ferrando C, Soro M, Canet J, Unzueta MC, Suarez F, Librero J, Peiro S, Llombart A, Delgado C, Leon I, Rovira L, Ramasco F, Granell M, Aldecoa C, Diaz O, Balust J, Garutti I, de la Matta M, Pensado A, Gonzalez R, Duran ME, Gallego L, Del Valle SG, Redondo FJ, Diaz P, Pestana D, Rodriguez A, Aguirre J, Garcia JM, Garcia J, Espinosa E, Charco P, Navarro J, Rodriguez C, Tusman G, Belda FJ; iPROVE investigators (Appendices 1 and 2). Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial. Trials. 2015 Apr 27;16:193. doi: 10.1186/s13063-015-0694-1. — View Citation

Ferrando C, Soro M, Unzueta C, Suarez-Sipmann F, Canet J, Librero J, Pozo N, Peiro S, Llombart A, Leon I, India I, Aldecoa C, Diaz-Cambronero O, Pestana D, Redondo FJ, Garutti I, Balust J, Garcia JI, Ibanez M, Granell M, Rodriguez A, Gallego L, de la Matta M, Gonzalez R, Brunelli A, Garcia J, Rovira L, Barrios F, Torres V, Hernandez S, Gracia E, Gine M, Garcia M, Garcia N, Miguel L, Sanchez S, Pineiro P, Pujol R, Garcia-Del-Valle S, Valdivia J, Hernandez MJ, Padron O, Colas 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. — View Citation

Hemmes SN, Severgnini P, Jaber S, Canet J, Wrigge H, Hiesmayr M, Tschernko EM, Hollmann MW, Binnekade JM, Hedenstierna G, Putensen C, de Abreu MG, Pelosi P, Schultz MJ. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery. Trials. 2011 May 6;12:111. doi: 10.1186/1745-6215-12-111. — View Citation

PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative pulmonary complications	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.	Until day seven or hospital discharge, whichever comes first
Secondary	Incidence of severe postoperative pulmonary complications	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	Until day seven or hospital discharge, whichever comes first
Secondary	Incidence of extrapulmonary pulmonary complications	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.	Until day seven or hospital discharge, whichever comes first
Secondary	Incidence of intraoperative complications	Defined as intraoperative hypotension; or need for rescue for desaturations; or need for vasoactive drugs.	Intraoperatively
Secondary	Incidence of intensive care unit admission	Incidence of intensive care unit admission during hospital stay	Until hospital discharge, death or 100 days, whichever comes first
Secondary	Hospital length of stay	Duration of hospital length of stay in days	Until hospital discharge, death or 100 days, whichever comes first
Secondary	Incidence of 7-day mortality	Mortality during the first seven days of hospitalization	Until day seven or hospital discharge, whichever comes first
Secondary	Incidence of in-hospital mortality	Mortality during hospitalization	Until hospital discharge, death or 100 days, whichever comes first
Secondary	Incidence of major postoperative complications	Collapsed composite of complications developing within the first seven postoperative combining severe postoperative pulmonary complications, sepsis, septic shock and/or acute kidney injury)	Until day seven or hospital discharge, whichever comes first