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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
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Major patient
  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:

  1. Contraindication to the use of NIV or HFO
  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

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

    First Posted
    June 25, 2020
    Last Updated
    July 9, 2020
    Sponsor
    University Hospital, Rouen
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    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

    Learn more about this trial

    Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study

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