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TerminatedNCT02823054VUPPAMUpdated Jun 12, 2026

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

An interventional study of EZ-Blocker in Coronary Artery Bypass, sponsored by Centre Hospitalier Universitaire, Amiens. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Prevention

Why this study was terminated
No inclusions since 2018.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Coronary Artery Bypass

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Keywords

  • elective surgery
  • CABG
  • One-lung ventilation
  • EZ Blockers
  • pleural effusion
03

In context

Pleural Effusion

324 studies on the registry are indexed under Pleural Effusion; 62 are open to participants now.

This study's enrollment of 35 is below the median of 63 across 212 interventional studies indexed under Pleural Effusion.

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Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
35 participants (actual)

Study arms

  • No intervention
    Standard group

    bi lung ventilation usual practice

  • Experimental
    EZ-Blocker group

    one lung ventilation 'EZ-Blocker'

    Device: EZ-Blocker

Interventions

  • DeviceEZ-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.

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What researchers measure

Primary outcomes

  1. Pleural effusions after coronary artery bypass graft surgery

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

    Time frame: Day 0

  2. absence of pneumothorax

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

    Time frame: Day 0

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Study locations

1 site
  • CHU Amiens
    Amiens, 800504, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02823054
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jul 6, 2016
Start date
Jan 3, 2017
Primary completion
Mar 1, 2022
Completion
Mar 1, 2022
Last update
Jun 12, 2026

Study contacts

Mathieu GUILBART, PhD
principal investigator · CHU Amiens
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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