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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.
The investigators propose to carry out a prospective randomized cross-over prospective physiological study comparing, Non-Invasive Ventilation and High Flow Oxygen Therapy in patients with chronic uncompensated heart failure. This stable population would make it possible to easily study variations in a physiological parameter without any added risk for the patient, but with all the pathophysiological parameters transposable to the situation of decompensated heart failure.
Indeed, it is accepted that the existence of heart failure with decreased left ventricular ejection fraction (LVEF) (< 40%) exposes patients to a high risk of congestive cardiac decompensation due to the associated presence of diastolic dysfunction1.
The study will be conducted using an alternating design, where a patient receives the two treatments one after the other ("cross-over"), because the alternating design, compared to the two parallel arm design, reduces the number of patients needed to show a given difference between High Flow Oxygen Therapy and Non-Invasive Ventilation at equal power, if there is neither an order-of-prescription effect ("period") nor a residual effect of the first treatment on the second treatment ("carry-over"). In order to avoid a residual effect on changes in pressure or oxygenation, a wash-out period on conventional oxygen therapy (O2C) should be set between the two treatments (High Flow Oxygen Therapy and Non-Invasive Ventilation) administered to the same patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFO/O2C/NIV | Other | High-flow oxygen therapy + O2C + Non invasive ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. ventricular function | Arterial pressure [mmHg] measured by Swan-Ganz catheter | Day 1 |
| Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. arterial oxygenation |
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Inclusion Criteria:
Exclusion Criteria:
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 :
Chronic advanced respiratory disease
Chronic treatment with NIV or CPAP at home
Non-operated aortic or mitral insufficiency ≥ II/IV
Administration of loop diuretics within 3 hours prior to inclusion for intravenous forms and within 6 hours for oral forms.
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth Surlemont, Dr | Contact | +33232881705 | Elisabeth.Surlemont@chu-rouen.fr | |
| Emmanuel Besnier, Dr | Contact | +332888283 | Emmanuel.Besnier@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Rouen | Recruiting | Rouen | 76031 | France |
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sequential assignment
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No applicable
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| NIV/O2C/HFO | Other | Non invasive ventilation + O2C + High-flow oxygen therapy |
|
Arterial oxygen saturation, SaO2 [%], measured by Swan-Ganz catheter |
| Day 1 |
| 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) | Day 1 |
| Patient comfort | Patient's evaluation of comfort on Visual Analog Scale (10 points) | Day 1 |