Non-invasive ventilation versus high-flow oxygen: effects on heart function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized cross-over physiological study in adults with chronic heart failure (LVEF <40%) who are extubated after cardiac surgery. Each participant receives both high-flow oxygen therapy and non-invasive ventilation separated by a washout period on standard oxygen, with treatment order randomized. Invasive monitoring including a pulmonary artery (Swan-Ganz) catheter and arterial line will record pulmonary pressures, cardiac output, and oxygenation during each intervention. The cross-over design reduces required sample size and isolates short-term hemodynamic effects of each respiratory support mode.

Why it matters

Who can join: the full rules

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

Where it's running

• Chu Rouen
  Rouen, France Recruiting

Study contacts

• Study coordinator: Elisabeth Surlemont, Dr
• Email: Elisabeth.Surlemont@chu-rouen.fr
• Phone: +33232881705

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Voice-based detection of heart failure deterioration using Noah Labs Vox

  This study tests whether a voice-analysis app can flag worsening heart failure in adults by comparing its alerts to standard weight-based monitoring.

  Recruiting Noah Labs · Boston, Massachusetts · NCT07870395

• Mobile-based telemedicine to improve quality of life for chronic heart failure patients

  We’re testing whether a mobile phone–based program that sends reminders, education, and follow-up can improve quality of life for adults with chronic heart failure in Ethiopia.

  Recruiting Select College · Addis Ababa · NCT07650474

• Restoring gut bacteria in adults with chronic heart failure

  This trial tests whether replacing gut bacteria with healthy donor bacteria (intestinal microbiota transplantation) can reduce inflammation and improve function in adults with chronic heart failure.

  Recruiting Phase 1 Columbia University · New York, New York · NCT07490054

• Biventricular or left bundle branch pacing to improve heart pumping after TAVI

  This research will try whether implanting a cardiac resynchronization device (biventricular or left bundle branch pacing) shortly after TAVI helps people who develop a persistent left bundle branch block and have mildly reduced heart function (EF 35%–55%).

  Recruiting Semmelweis University Heart and Vascular Center · Budapest · NCT07434193

• Vericiguat for right‑ventricular function and heart remodeling in HFrEF

  This study will test whether adding vericiguat to usual heart‑failure treatment helps adults with stable HFrEF improve right‑ventricular function and heart remodeling over 12 months.

  Recruiting at 4 sites Phase 4 University Medical Centre Ljubljana · Izola and 3 other locations · NCT07405944

• Safety of finerenone in adults with chronic heart failure (LVEF ≥ 40%) in South Korea

  This project will see if finerenone is safe for adults in South Korea who have chronic heart failure with a left ventricular ejection fraction of 40% or higher while they take it as usual care.

  Recruiting Bayer · Multiple Locations · NCT07379840

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.