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

Centre Hospitalier Universitaire, Amiens

Status: Unknown

Conditions: Coronary Artery Bypass

Treatments: Device: EZ-Blocker

Study type: Interventional

Funder types: Other

Identifiers

NCT02823054

PI2015_843_0013

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Standard group

No Intervention group

Description:

bi lung ventilation usual practice

EZ-Blocker group

Experimental group

Description:

one lung ventilation 'EZ-Blocker'

Treatment:

Device: EZ-Blocker