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Can a simple oxygen mask help failing hearts?
NCT ID NCT04471129
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether high-flow oxygen therapy can improve heart function in people with chronic heart failure who have recently had heart surgery. Researchers will compare it to non-invasive ventilation (a breathing machine) in 30 adults. The goal is to see if the oxygen therapy lowers pressure in the heart's chambers, which could ease the heart's workload.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-flow oxygen therapy and non-invasive ventilation
- What this could lead to
- If it works, this could point toward a gentler breathing support option for heart failure patients after surgery, potentially reducing heart strain.
- What could go wrong
- This is a very small, early-stage study with only 30 participants, so results may not apply to all heart failure patients. The effects are uncertain and may not lead to a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2020
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Major patient 2. Patient who has undergone cardiac surgery with extracorporeal circulation for more than 24 hours and has been extubated for at least 6 hours. 3. Pre-operative heart failure with left ventricular ejection fraction \< 40%. 4. Invasive monitoring by pulmonary arterial catheter (Swan-Ganz) with transpulmonary thermodilution and by radial arterial catheter intended for use in the intra- and post-operative monitoring of the patient. 5. Treatment with conventional oxygen therapy (O2C) without an increase in O2 flow for more than 30 minuts, without signs of hypoxemia (SpO292%) 6. Stable hemodynamic parameters: no changes in hemodynamic parameters (arterial pressures and pulmonary and cardiac index) by more than 10% over the 30 minutes prior to inclusion and no increase in cardiotropic medication for at least 30 minutes. 7. Patient with an oxygenation rate ≤ 6L 8. For women of child-bearing age: negative pregnancy test at inclusion 9. Person who has read and understood the information letter and signed the consent form 10. Affiliation to a social security scheme Exclusion Criteria: 1. Contraindication to the use of NIV or HFO 2. Patient with orotracheal intubation or tracheotomy 3. Renal failure with hemodialysis or hemofiltration 4. Uncontrolled state of shock (PAS\<90 mmHg and/or cardiac index\<1.8 L/min/m² and/or norepinephrine\>0.2 μg/kg/min and/or dobutamine\>10 μg/kg/min) 5. Acute respiratory failure as defined by : * clinical signs: respiratory rate \>35/min, signs of struggle, SpO2\<92% on O2C * indication for treatment with NIV or HFO at the discretion of the clinician * oxygen dependency requiring O2C\>6L/min O2C flow at the oxygen mask 6. Chronic advanced respiratory disease 7. Chronic treatment with NIV or CPAP at home 8. Non-operated aortic or mitral insufficiency ≥ II/IV 9. Administration of loop diuretics within 3 hours prior to inclusion for intravenous forms and within 6 hours for oral forms. 10. Presence of altered consciousness defined by a Glasgow score \< 15/15 or cognitive dysfunction defined by a CAM-ICU score \> 0/4 11. Pregnant or parturient or nursing woman or proven lack of effective contraception 12. Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship 13. Person participating in another trial / having participated in another trial that may interfere with the procedures that are the subject of the research within a 4-week time frame
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chu Rouen
RECRUITINGRouen, 76031, France
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