Status:
UNKNOWN
Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study
Lead Sponsor:
University Hospital, Rouen
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 pulmonar...
Detailed Description
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 unc...
Eligibility Criteria
Inclusion
- 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%)
- 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.
- Patient with an oxygenation rate ≤ 6L
- For women of child-bearing age: negative pregnancy test at inclusion
- Person who has read and understood the information letter and signed the consent form
- Affiliation to a social security scheme
Exclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04471129
Start Date
July 15 2020
End Date
October 15 2022
Last Update
July 15 2020
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