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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03937375
Other study ID # REPEAT
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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