Ventilation in Cardiac Surgery (VENICE)

August 18, 2017 updated by: University Hospital, Caen

International Multicentre Observational Trial of Perioperative Ventilatory Management in Cardiac Surgery

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.
Other: Survey
An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.
Other Names:
  • not adapted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of using positive end-expiratory pressure
Time Frame: 1 day
(PEEP)> 5 cmH2O
1 day
incidence of using at least 2 alveolar lung recruitment manoeuvres
Time Frame: 1 day
percent
1 day
incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres
Time Frame: 1 day
percent
1 day
incidence of postoperative pulmonary complications
Time Frame: 1 month postoperatively
percent
1 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Marc-Olivier Fischer, MD, PhD, University Hospital of Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

August 18, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 18, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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