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

NCT04471129 | Recruiting

• 1 other identifier: 2019/0400/HP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Heart Failure

Keywords

chronic heart failure; heart surgery; invasive mechanical ventilation; high flow oxygen therapy

Outcome Measures

Primary Outcomes (1)

• High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures

  Difference between High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures as assessed by the occluded pulmonary artery occlusion pressure (in mmHg) measured by Swan-Ganz pulmonary artery catheterization

  Day 1

Secondary Outcomes (4)

• Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. ventricular function

  Day 1

• Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. arterial oxygenation

  Day 1

• Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. change in pulmonary volume

  Day 1

• Patient comfort

  Day 1

Study Arms (2)

High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation

OTHER

oxygenation first by High-Flow Oxygen Therapy, then by O2C, then by Non-Invasive Ventilation

Other: HFO/O2C/NIV

Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy

OTHER

oxygenation first by Non-Invasive Ventilation, then by O2C, then by High-Flow Oxygen Therapy

Other: NIV/O2C/HFO

Interventions

HFO/O2C/NIV OTHER

High-flow oxygen therapy + O2C + Non invasive ventilation

High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation

NIV/O2C/HFO OTHER

Non invasive ventilation + O2C + High-flow oxygen therapy

Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major patient
• Patient who has undergone cardiac surgery with extracorporeal circulation for more than 24 hours and has been extubated for at least 6 hours.
• Pre-operative heart failure with left ventricular ejection fraction \< 40%.
• 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.
• Treatment with conventional oxygen therapy (O2C) without an increase in O2 flow for more than 30 minuts, without signs of hypoxemia (SpO292%)
• Patient with an oxygenation rate ≤ 6L
• Person who has read and understood the information letter and signed the consent form
• Affiliation to a social security scheme

You may not qualify if:

• Contraindication to the use of NIV or HFO
• Patient with orotracheal intubation or tracheotomy
• Renal failure with hemodialysis or hemofiltration
• 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)
• 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
• Chronic advanced respiratory disease
• Chronic treatment with NIV or CPAP at home
• Non-operated aortic or mitral insufficiency ≥ II/IV
• Presence of altered consciousness defined by a Glasgow score \< 15/15 or cognitive dysfunction defined by a CAM-ICU score \> 0/4
• Pregnant or parturient or nursing woman or proven lack of effective contraception
• Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Chu Rouen

Rouen, 76031, France

RECRUITING

Central Study Contacts

Elisabeth Surlemont, Dr

CONTACT

+33232881705; Elisabeth.Surlemont@chu-rouen.fr

Emmanuel Besnier, Dr

CONTACT

+332888283; Emmanuel.Besnier@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No applicable
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: sequential assignment

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 15, 2020
• Study Start: September 16, 2020
• Primary Completion (Estimated): September 16, 2026
• Study Completion (Estimated): September 16, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

FR (1)