One-lung Ventilation During Internal Thoracic Artery Grafting in Cardiac Surgery
VUPPAM
1 other identifier
interventional
208
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2016
CompletedFirst Posted
Study publicly available on registry
July 6, 2016
CompletedStudy Start
First participant enrolled
January 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedAugust 10, 2018
August 1, 2018
3 years
June 28, 2016
August 9, 2018
Conditions
Keywords
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 INTERVENTIONbi lung ventilation usual practice
EZ-Blocker group
EXPERIMENTALone lung ventilation 'EZ-Blocker'
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 800504, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathieu GUILBART, PhD
CHU Amiens
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- 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 4, 2017
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
August 10, 2018
Record last verified: 2018-08