Coronary Artery BypassVUPPAMNCT02823054
One-lung Ventilation During Internal Thoracic Artery Grafting in Cardiac Surgery
A study testing EZ-Blocker in people with Coronary Artery Bypass, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- EZ-Blocker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2017to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective CABG surgery with internal thoracic artery, with patient consent.
- Patient who have french social security
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- EZ-Blocker
- Keywords
- elective surgery, CABG, One-lung ventilation, EZ Blockers, pleural effusion
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EZ-BlockerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | No intervention | bi lung ventilation usual practice |
| EZ-Blocker group | Experimental | one lung ventilation 'EZ-Blocker' Receives: Device: EZ-Blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleural effusions after coronary artery bypass graft surgery
quantifying the number of thoracic drains (0, 1 or 2), as accidental or voluntary pleural effusion
Measured: Day 0
absence of pneumothorax
verify the absence of pneumothorax to X-ray chest ( not drained pleural effusion).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start3 Jan 2017
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Why it stopped: No inclusions since 2018.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu GUILBART, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823054
- Sponsor's protocol ID
- PI2015_843_0013
- Acronym
- VUPPAM
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-lung Ventilation During Internal Thoracic Artery Grafting in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02823054
- Acronym / sponsor ID
- VUPPAM / PI2015_843_0013
- Conditions
- Coronary Artery Bypass
- Keywords
- elective surgery, CABG, One-lung ventilation, EZ Blockers, pleural effusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No inclusions since 2018.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | No intervention | –bi lung ventilation usual practice |
| EZ-Blocker group | Experimental | Device: EZ-Blockerone lung ventilation 'EZ-Blocker' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective CABG surgery with internal thoracic artery, with patient consent.
- Patient who have french social security
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EZ-Blockerthe 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. | Device | EZ-Blocker group |
Primary outcome
Pleural effusions after coronary artery bypass graft surgery
Time frame: Day 0
quantifying the number of thoracic drains (0, 1 or 2), as accidental or voluntary pleural effusion
absence of pneumothorax
Time frame: Day 0
verify the absence of pneumothorax to X-ray chest ( not drained pleural effusion).
Results and safety
The study was stopped early (reason given: No inclusions since 2018.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu GUILBART, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EZ-Blocker in people with Coronary Artery Bypass, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No inclusions since 2018.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pleural effusions after coronary artery bypass graft surgery (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.