Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study
NCT ID: NCT04471129
Last Updated: 2020-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-07-15
2022-10-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation
oxygenation first by High-Flow Oxygen Therapy, then by O2C, then by Non-Invasive Ventilation
HFO/O2C/NIV
High-flow oxygen therapy + O2C + Non invasive ventilation
Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy
oxygenation first by Non-Invasive Ventilation, then by O2C, then by High-Flow Oxygen Therapy
NIV/O2C/HFO
Non invasive ventilation + O2C + High-flow oxygen therapy
Interventions
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HFO/O2C/NIV
High-flow oxygen therapy + O2C + Non invasive ventilation
NIV/O2C/HFO
Non invasive ventilation + O2C + High-flow oxygen therapy
Eligibility Criteria
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Inclusion Criteria
2. Patient who has undergone cardiac surgery with extracorporeal circulation for more than 24 hours and has been extubated for at least 6 hours.
3. Pre-operative heart failure with left ventricular ejection fraction \< 40%.
4. 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.
5. Treatment with conventional oxygen therapy (O2C) without an increase in O2 flow for more than 30 minuts, without signs of hypoxemia (SpO292%)
6. 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.
7. Patient with an oxygenation rate ≤ 6L
8. For women of child-bearing age: negative pregnancy test at inclusion
9. Person who has read and understood the information letter and signed the consent form
10. Affiliation to a social security scheme
Exclusion Criteria
2. Patient with orotracheal intubation or tracheotomy
3. Renal failure with hemodialysis or hemofiltration
4. 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)
5. 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
6. Chronic advanced respiratory disease
7. Chronic treatment with NIV or CPAP at home
8. Non-operated aortic or mitral insufficiency ≥ II/IV
9. Administration of loop diuretics within 3 hours prior to inclusion for intravenous forms and within 6 hours for oral forms.
10. Presence of altered consciousness defined by a Glasgow score \< 15/15 or cognitive dysfunction defined by a CAM-ICU score \> 0/4
11. Pregnant or parturient or nursing woman or proven lack of effective contraception
12. Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
13. 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
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2019/0400/HP
Identifier Type: -
Identifier Source: org_study_id
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