Clinical trial NCT03255356: Ventilation in Cardiac Surgery
Official title: International Multicentre Observational Trial of Perioperative Ventilatory Management in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Complication
Respiration, Artificial
Anesthesia, General
Bypass, Cardiopulmonary
Keywords: Postoperative pulmonary complications
Protective mechanical ventilation
Alveolar lung recruitment manoeuvres
Cardiac Surgery Procedures
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult cardiac surgery patients with cardiopulmonary bypass (CPB).

Brief summary: The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period.

Detailed description: This is a International Multicentre Observational Trial on all adult cardiac surgery patients with cardiopulmonary bypass (CPB).

Eligibility criteria: Inclusion Criteria:

* All consecutive cardiac surgery patients with CPB during one predefined period,
* Elective or urgent surgery as defined by EuroSCORE2.

Exclusion Criteria:

* Refusal of consent,
* Pregnant women,
* Age \< 18 years,
* Heart transplant, ECLS, ventricular assist
* Emergency or salvage surgery as defined by EuroSCORE2

Primary outcomes:
measure: incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight)
timeFrame: 1 day
Secondary outcomes:
measure: incidence of using positive end-expiratory pressure
timeFrame: 1 day
measure: incidence of using at least 2 alveolar lung recruitment manoeuvres
timeFrame: 1 day
measure: incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres
timeFrame: 1 day
measure: incidence of postoperative pulmonary complications
timeFrame: 1 month postoperatively
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CUB Erasm, Université libre de Bruxelles
city: Brasil
country: Brazil
facility: Universidade Federal de São Paulo (UNIFESP)
city: Praha
country: Czechia
facility: General University Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Jena
country: Germany
facility: Klinik für Anästhesiologie und Intensivmedizin
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria
city: Osaki
country: Japan
facility: Osaka city University Graduate school of Medecine
city: Amsterdam
country: Netherlands
facility: VU University Hospital
city: Trondheim
country: Norway
facility: St Olav University Hospital
city: Wrocław
country: Poland
facility: Wroclaw Medical University
Study officials:
affiliation: University Hospital of Caen
name: Marc-Olivier Fischer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
citation: Lellouche F, Delorme M, Bussieres J, Ouattara A. Perioperative ventilatory strategies in cardiac surgery. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):381-95. doi: 10.1016/j.bpa.2015.08.006. Epub 2015 Sep 4.
citation: Guldner A, Kiss T, Serpa Neto A, Hemmes SN, Canet J, Spieth PM, Rocco PR, Schultz MJ, Pelosi P, Gama de Abreu M. Intraoperative protective mechanical ventilation for prevention of postoperative pulmonary complications: a comprehensive review of the role of tidal volume, positive end-expiratory pressure, and lung recruitment maneuvers. Anesthesiology. 2015 Sep;123(3):692-713. doi: 10.1097/ALN.0000000000000754.