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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
HFO/O2C/NIV
Other interventionHigh-flow oxygen therapy + O2C + Non invasive ventilation
NIV/O2C/HFO
Other interventionNon invasive ventilation + O2C + High-flow oxygen therapy
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. ventricular function
Arterial pressure \[mmHg\] measured by Swan-Ganz catheter
Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. arterial oxygenation
Arterial oxygen saturation, SaO2 \[%\], measured by Swan-Ganz catheter
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)
Patient comfort
Patient's evaluation of comfort on Visual Analog Scale (10 points)
Sponsors and contacts
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