Actively Recruiting
Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study
Led by University Hospital, Rouen · Updated on 2026-03-16
30
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators hypothesize that the airway pressures generated by High Flow Oxygen Therapy could have a beneficial impact in patients with heart failure, particularly by lowering capillary pulmonary arterial pressures. However, results compared to Non-Invasive Ventilation are difficult to predict due to the lack of data in the literature.
CONDITIONS
Official Title
Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults who have undergone cardiac surgery with extracorporeal circulation lasting more than 24 hours and have been extubated for at least 6 hours
- Pre-operative heart failure with left ventricular ejection fraction less than 40%
- Invasive monitoring by pulmonary arterial catheter (Swan-Ganz) and radial arterial catheter for intra- and post-operative monitoring
- Receiving conventional oxygen therapy without increased oxygen flow for more than 30 minutes and no signs of hypoxemia (SpO2 ≥ 92%)
- Stable hemodynamic parameters with no significant changes or increases in cardiotropic medication for at least 30 minutes
- Oxygenation rate of 6 liters or less
- Negative pregnancy test at inclusion for women of child-bearing age
- Able to understand information and provide signed consent
- Affiliated with a social security scheme
You will not qualify if you...
- Contraindication to the use of Non-Invasive Ventilation or High Flow Oxygen Therapy
- Currently intubated or with a tracheotomy
- Renal failure requiring hemodialysis or hemofiltration
- Uncontrolled shock with low blood pressure or low cardiac index or high doses of vasoactive medications
- Acute respiratory failure with respiratory distress signs or oxygen saturation below 92% on oxygen therapy
- Oxygen dependency requiring more than 6 liters per minute oxygen flow
- Advanced chronic respiratory disease
- Chronic home treatment with Non-Invasive Ventilation or CPAP
- Moderate or severe aortic or mitral valve insufficiency (grade ≥ II/IV) not operated
- Recent administration of loop diuretics within specified time frames
- Altered consciousness or cognitive dysfunction
- Pregnant, nursing, or lack of effective contraception
- Legal restrictions such as judicial protection or deprivation of liberty
- Participation in another clinical trial within the past 4 weeks that could interfere with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chu Rouen
Rouen, France, 76031
Actively Recruiting
Research Team
E
Elisabeth Surlemont, Dr
CONTACT
E
Emmanuel Besnier, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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