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

NCT02823054 | Terminated

• 1 other identifier: PI2015_843_0013
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass

Keywords

elective surgery; CABG; One-lung ventilation; EZ Blockers; pleural effusion

Outcome Measures

Primary Outcomes (2)

• Pleural effusions after coronary artery bypass graft surgery

  quantifying the number of thoracic drains (0, 1 or 2), as accidental or voluntary pleural effusion

  Day 0

• absence of pneumothorax

  verify the absence of pneumothorax to X-ray chest ( not drained pleural effusion).

  Day 0

Study Arms (2)

Standard group

NO INTERVENTION

bi lung ventilation usual practice

EZ-Blocker group

EXPERIMENTAL

one lung ventilation 'EZ-Blocker'

Device: EZ-Blocker

Interventions

EZ-Blocker 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.

EZ-Blocker group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 800504, France

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Mathieu GUILBART, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 6, 2016
• Study Start: January 3, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

FR (1)