Ventilation in Cardiac Surgery

Anesthesia, General Clinical Trial

— VENICE  

Official title:

International Multicentre Observational Trial of Perioperative Ventilatory Management in Cardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03255356
• Other study ID #: 16-081
• Status: Not yet recruiting
• Phase: N/A
• First received: June 12, 2017
• Last updated: August 18, 2017
• Start date: November 1, 2017
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: University Hospital, Caen
• Contact: Marc-Olivier Fischer, MD, PhD
• Phone: +33 2 31 06 31 06
• Email: fischer-mo[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General
• Bypass, Cardiopulmonary
• Respiration, Artificial
• Respiratory Complication

Intervention

Other:
• Survey
An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.

Locations

Country	Name	City	State
Belgium	CUB Erasm, Université libre de Bruxelles	Brussels
Brazil	Universidade Federal de São Paulo (UNIFESP)	Brasil
Czechia	General University Hospital	Praha
France	Caen University Hospital	Caen
Germany	Klinik für Anästhesiologie und Intensivmedizin	Jena
Italy	Azienda Ospedaliera Universitaria	Pisa
Japan	Osaka city University Graduate school of Medecine	Osaki
Netherlands	VU University Hospital	Amsterdam
Norway	St Olav University Hospital	Trondheim
Poland	Wroclaw Medical University	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Countries where clinical trial is conducted

Belgium,  Brazil,  Czechia,  France,  Germany,  Italy,  Japan,  Netherlands,  Norway,  Poland, 

References & Publications (3)

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. — View Citation

Güldner 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. Review. — View Citation

Lellouche F, Delorme M, Bussières 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight)	percent	1 day
Secondary	incidence of using positive end-expiratory pressure	(PEEP)> 5 cmH2O	1 day
Secondary	incidence of using at least 2 alveolar lung recruitment manoeuvres	percent	1 day
Secondary	incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres	percent	1 day
Secondary	incidence of postoperative pulmonary complications	percent	1 month postoperatively