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

Coronary Artery Bypass Clinical Trial

— VUPPAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02823054
• Other study ID #: PI2015_843_0013
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2017
• Est. completion date: January 2020

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Mathieu GUILBART, PhD
• Phone: +33 3 22 08 78 35
• Email: guilbart.mathieu[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	absence of pneumothorax	verify the absence of pneumothorax to X-ray chest ( not drained pleural effusion).	Day 0