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

Not Applicable

• Conditions: Coronary Artery Bypass
• Interventions: Device: EZ-Blocker

• Registration Number: NCT02823054
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-06
• Study Start: 2017-01-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EZ-Blocker group	EZ-Blocker	one lung ventilation 'EZ-Blocker'

Primary Outcome Measures

Name	Time	Method
Pleural effusions after coronary artery bypass graft surgery	Day 0	quantifying the number of thoracic drains (0, 1 or 2), as accidental or voluntary pleural effusion
absence of pneumothorax	Day 0	verify the absence of pneumothorax to X-ray chest ( not drained pleural effusion).

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France