Impact of Hyperoxia During Cardiopulmonary

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-11

Study Completion Date

2019-03-30

Brief Summary

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The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass by his heart preconditioning effect is associated with a lower incidence of cardiac arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of myocardial ischemia-reperfusion injury in cardiac surgery postoperative.

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Detailed Description

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Conditions

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Cardiac Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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normoxia

During cardiopulmonary bypass inspired fraction of oxygen is adapted to maintained a oxygen arterial pressure below 150 mmHg.

Group Type EXPERIMENTAL

medical oxygen

Intervention Type DRUG

hyperoxia

During cardiopulmonary bypass inspired fraction of oxygen is set to 100 %.

Group Type ACTIVE_COMPARATOR

medical oxygen

Intervention Type DRUG

Interventions

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medical oxygen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Major patient ≥ 18 years
* Patient operated cardiac surgery for myocardial revascularization (CABG) or surgical correction of valvular or combined surgery (CABG and valve disease) or ascending aortic surgery
* Signed Consent
* Affiliation to social security

Exclusion Criteria

* Permanent atrial fibrillation
* Cordarone therapy,
* Pregnant woman
* Patient under guardianship or trusteeship or private public law
* Internal pacemaker
* Hypothermia,
* Patient refusal,
* Cardiac surgery without extracorporal circulation (ECC),
* Participation in another study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No