Breathing device tested to reopen collapsed lungs after heart surgery
NCT ID NCT02262182
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
After heart surgery, part of a lung can collapse, a common problem called atelectasis. Researchers are testing whether adding a breathing device called EzPAP, which provides positive pressure on exhale, to standard manual chest physiotherapy helps clear this collapse better than physiotherapy alone. The trial enrolls 80 adults who develop atelectasis after scheduled heart surgery with cardiopulmonary bypass. Half receive EzPAP sessions twice a day plus chest physiotherapy, and half receive chest physiotherapy only. Researchers compare chest X-ray scores after two days and track oxygen levels, breathing, heart rate, pain, and length of intensive care and hospital stay.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EzPAP positive expiratory pressure device added to manual chest physiotherapy
- What this could lead to
- If it works, adding EzPAP to standard chest physiotherapy could help patients clear collapsed lung areas faster after heart surgery and possibly shorten intensive care and hospital stays.
- What could go wrong
- This is a small, single-center trial with 80 patients, so results may not apply broadly. The device could add little benefit over chest physiotherapy alone, and some patients may find the breathing sessions uncomfortable or tiring.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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80 people
The number who actually took part.
- Start date
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Nov 2014
- Finished
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Sep 2016
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients admitted in ICU after cardiac surgery by sternotomy with cardiopulmonary bypass presenting a pulmonary atelectasis after extubation, diagnosed by chest X-ray in postoperative period (day1 to day 2). * Patients over 18 years of age * Informed patient Exclusion Criteria: * Cardiac arrhythmia * Hemodynamic instability (mean blood pressure \< 65 mmHg or \> 95 mmHg) * Respiratory rate \> 35/min * Undrained pneumothorax * Predictable trachea intubation or emergent surgery * Patient oral refusal
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Nantes Universitary Hospital
Saint-Herblain, 44805, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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