One-lung Ventilation During Internal Thoracic Artery Grafting in Cardiac Surgery

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-04

Study Completion Date

2020-01-31

Brief Summary

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Coronary artery bypass grafting is a current cardiac surgery. Internal thoracic artery is usually taking to restore coronary revascularization, and its dissection can lead to accidental or voluntary pleural effusions. Respiratory complications are frequent, due to the drainage required. In this study, the investigators propose one-lung ventilation to facilitate artery grafting and surgical procedure. The investigators will include all adult patients with elective coronary artery bypass surgery (CABG) by internal thoracic artery, in a prospective, controlled, randomized and monocentric study. The main objective is to demonstrate that one-lung ventilation using EZ-Blocker can reduce pleural effusion defined by presence of drainage and/or pneumothorax on X-ray chest in the ICU.

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Detailed Description

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Conditions

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Coronary Artery Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard group

bi lung ventilation usual practice

Group Type NO_INTERVENTION

No interventions assigned to this group

EZ-Blocker group

one lung ventilation 'EZ-Blocker'

Group Type EXPERIMENTAL

EZ-Blocker

Intervention Type DEVICE

the Blocker group, the EZ-Blocker will be set up after anesthesia induction and standard orotracheal intubation to allow lung exclusion during homolateral internal thoracic artery sampling, and thus a one-lung ventilation. This material will be removed at the end of surgical surgery.

Interventions

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EZ-Blocker

the Blocker group, the EZ-Blocker will be set up after anesthesia induction and standard orotracheal intubation to allow lung exclusion during homolateral internal thoracic artery sampling, and thus a one-lung ventilation. This material will be removed at the end of surgical surgery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* elective CABG surgery with internal thoracic artery, with patient consent.
* Patient who have french social security

Exclusion Criteria

* Cardiac or thoracic past-history
* polyurethane allergy
* guardianship patient
* endotracheal intern diameter too small to allow the EZ-Blocker introduction or the fiberscope
* use of LASER immediately near the EZ-Blocker

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No