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

Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study

This trial tests whether high-flow oxygen or non-invasive ventilation better lowers pulmonary artery pressure in adults with chronic heart failure and reduced ejection fraction after cardiac surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Locations: 1 site (Rouen)
• Trial ID: NCT04471129 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults post-cardiac surgery who are extubated, hemodynamically stable, have chronic heart failure with LVEF <40%, are on low-flow oxygen (≤6 L/min), and have invasive pulmonary artery monitoring in place.

Not a fit: Patients who are unstable, severely hypoxemic, not invasively monitored, not post-cardiac surgery, or who require immediate higher-level respiratory support are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the results could identify which noninvasive respiratory support more effectively reduces pulmonary pressures and might lower the risk of cardiac decompensation after surgery.

How similar studies have performed: There is limited published data directly comparing high-flow oxygen and non-invasive ventilation in this heart failure population, so this direct comparison is relatively novel and unproven.

Eligibility criteria

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 this trial is running

Rouen

• Chu Rouen — Rouen, France (Recruiting)

Study contacts

• Study coordinator: Elisabeth Surlemont, Dr

Conditions Chronic Heart Failure; chronic heart failure; heart surgery; invasive mechanical ventilation; high flow oxygen therapy