Ventilation in Cardiac Surgery

NCT03255356 | Unknown

• 1 other identifier: 16-081
• Study Type: observational
• Target: 1,000
• Locations: 10 countries
• Sites: 10

Brief Summary

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

Conditions

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

Keywords

Postoperative pulmonary complications; Protective mechanical ventilation; Alveolar lung recruitment manoeuvres; Cardiac Surgery Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• incidence of using positive end-expiratory pressure

  1 day

• incidence of using at least 2 alveolar lung recruitment manoeuvres

  1 day

• incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres

  1 day

• incidence of postoperative pulmonary complications

  1 month postoperatively

Study Arms (1)

Cohort

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

Other: Survey

Interventions

Survey OTHER

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

Also known as: not adapted

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult cardiac surgery patients with cardiopulmonary bypass (CPB).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (10)

CUB Erasm, Université libre de Bruxelles

Brussels, 1070, Belgium

Location

Universidade Federal de São Paulo (UNIFESP)

Brasil, Brazil

Location

General University Hospital

Prague, Czechia

Location

Caen University Hospital

Caen, 14 000, France

Location

Klinik für Anästhesiologie und Intensivmedizin

Jena, 07747, Germany

Location

Azienda Ospedaliera Universitaria

Pisa, Italy

Location

Osaka city University Graduate school of Medecine

Ōsaki, 545-8586, Japan

Location

VU University Hospital

Amsterdam, Netherlands

Location

St Olav University Hospital

Trondheim, Norway

Location

Wroclaw Medical University

Wroclaw, Poland

Location

Related 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.

  PMID: 23902482 BACKGROUND

• 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.

  PMID: 26643102 BACKGROUND

• 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.

  PMID: 26120769 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marc-Olivier Fischer, MD, PhD

  University Hospital of Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc-Olivier Fischer, MD, PhD

CONTACT

+33 2 31 06 31 06; fischer-mo@chu-caen.fr

Jennifer Brunet, MD

CONTACT

33 2 31 06 31 06; brunet-j@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: August 21, 2017
• Study Start: November 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); BE (1); PL (1); FR (1); JP (1); DE (1); CZ (1); IT (1); NL (1); NO (1)