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Clinical Trials/NCT03255356
NCT03255356
Unknown
N/A

International Multicentre Observational Trial of Perioperative Ventilatory Management in Cardiac Surgery

University Hospital, Caen10 sites in 10 countries1,000 target enrollmentNovember 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Complication
Sponsor
University Hospital, Caen
Enrollment
1000
Locations
10
Primary Endpoint
incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight)
Last Updated
8 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
December 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight)

Time Frame: 1 day

percent

Secondary Outcomes

  • incidence of postoperative pulmonary complications(1 month postoperatively)
  • 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)

Study Sites (10)

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