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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • HFO/O2C/NIV

    Other intervention

    High-flow oxygen therapy + O2C + Non invasive ventilation

  • NIV/O2C/HFO

    Other intervention

    Non invasive ventilation + O2C + High-flow oxygen therapy

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: High-Flow Oxygen Therapy, followed by Non-Invasive VentilationOther 1 intervention
Group B: Non-Invasive Ventilation, followed by High-Flow Oxygen TherapyOther 1 intervention

Trial outcomes

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

Time frame
Day 1

Secondary outcomes

1

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

Arterial pressure \[mmHg\] measured by Swan-Ganz catheter

Time frame
Day 1
2

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

Arterial oxygen saturation, SaO2 \[%\], measured by Swan-Ganz catheter

Time frame
Day 1
3

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

End-expiratory lung impedance (mean of 3 measures), measured by PulmoVista (Draeger, Germany)

Time frame
Day 1
4

Patient comfort

Patient's evaluation of comfort on Visual Analog Scale (10 points)

Time frame
Day 1

Other outcomes

Sponsors and contacts

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