Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study (HiFlow-Heart)
Primary Purpose
Chronic Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HFO/O2C/NIV
NIV/O2C/HFO
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring chronic heart failure, heart surgery, invasive mechanical ventilation, high flow oxygen therapy
Eligibility Criteria
Inclusion Criteria:
- 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 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 :
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation
Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy
Arm Description
oxygenation first by High-Flow Oxygen Therapy, then by O2C, then by Non-Invasive Ventilation
oxygenation first by Non-Invasive Ventilation, then by O2C, then by High-Flow Oxygen Therapy
Outcomes
Primary Outcome Measures
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 Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04471129
Brief Title
Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study
Acronym
HiFlow-Heart
Official Title
Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2020 (Anticipated)
Primary Completion Date
July 15, 2022 (Anticipated)
Study Completion Date
October 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 pulmonary arterial pressures. However, results compared to Non-Invasive Ventilation are difficult to predict due to the lack of data in the literature.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
chronic heart failure, heart surgery, invasive mechanical ventilation, high flow oxygen therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
sequential assignment
Masking
None (Open Label)
Masking Description
No applicable
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation
Arm Type
Other
Arm Description
oxygenation first by High-Flow Oxygen Therapy, then by O2C, then by Non-Invasive Ventilation
Arm Title
Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy
Arm Type
Other
Arm Description
oxygenation first by Non-Invasive Ventilation, then by O2C, then by High-Flow Oxygen Therapy
Intervention Type
Other
Intervention Name(s)
HFO/O2C/NIV
Intervention Description
High-flow oxygen therapy + O2C + Non invasive ventilation
Intervention Type
Other
Intervention Name(s)
NIV/O2C/HFO
Intervention Description
Non invasive ventilation + O2C + High-flow oxygen therapy
Primary Outcome Measure Information:
Title
High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures
Description
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 Outcome Measure Information:
Title
Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. ventricular function
Description
Arterial pressure [mmHg] measured by Swan-Ganz catheter
Time Frame
Day 1
Title
Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. arterial oxygenation
Description
Arterial oxygen saturation, SaO2 [%], measured by Swan-Ganz catheter
Time Frame
Day 1
Title
Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. change in pulmonary volume
Description
End-expiratory lung impedance (mean of 3 measures), measured by PulmoVista (Draeger, Germany)
Time Frame
Day 1
Title
Patient comfort
Description
Patient's evaluation of comfort on Visual Analog Scale (10 points)
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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 :
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Surlemont, Dr
Phone
+33232881705
Email
Elisabeth.Surlemont@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel Besnier, Dr
Phone
+332888283
Email
Emmanuel.Besnier@chu-rouen.fr
12. IPD Sharing Statement
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Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study
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