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Therapy With High-flow Oxygen by Nasal Cannula vs Noninvasive Ventilation in Patients With Acute Hypoxemic Respiratory Failure: a Crossover Physiologic Study (THIFON)

Primary Purpose

Hypoxemia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optiflow (High-flow Nasal Cannula)
Non-invasive Ventilation
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypoxemia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Hypoxemia defined by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2:FiO2) ≤ 300 while the patient is breathing oxygen through NHF for at least 15 minutes;
  2. Respiratory rate > 25 breaths/minute;
  3. Partial pressure of arterial carbon dioxide (PaCO2) ≤ 45 mmHg;
  4. Absence of clinical history of underlying chronic respiratory failure.

Exclusion Criteria:

  1. Lack of consent;
  2. Age < 18 years;
  3. Invasive mechanical ventilation for > 48 hours in the same hospital admission
  4. Immediate need for intubation;
  5. Previous inclusion in the present study;
  6. Systolic arterial pressure < 90 mmHg after optimal fluid therapy;
  7. Cardiogenic pulmonary edema;
  8. Glasgow Coma Scale < 12;
  9. Imminent death;
  10. Contraindications to noninvasive ventilation;
  11. Tracheostomy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    High-Flow Nasal Cannula

    Noninvasive ventilation

    Arm Description

    Outcomes

    Primary Outcome Measures

    the intra-tidal ventilation heterogeneity index
    the intra-tidal ventilation heterogeneity index (VtHit) assessed by electrical impedance tomography (EIT)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 5, 2019
    Last Updated
    March 5, 2019
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03865056
    Brief Title
    Therapy With High-flow Oxygen by Nasal Cannula vs Noninvasive Ventilation in Patients With Acute Hypoxemic Respiratory Failure: a Crossover Physiologic Study
    Acronym
    THIFON
    Official Title
    Therapy With High-flow Oxygen by Nasal Cannula vs Noninvasive Ventilation in Patients With Acute Hypoxemic Respiratory Failure: a Crossover Physiologic Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 15, 2019 (Anticipated)
    Primary Completion Date
    March 15, 2021 (Anticipated)
    Study Completion Date
    March 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Health Network, Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background and rationale: A large multicenter randomized controlled trial demonstrated that in patients with hypoxemic non-hypercapnic respiratory failure treatment with nasal high flow oxygen (NHF) resulted in a reduction of the endotracheal intubation rate (38%) compared with noninvasive ventilation (NIV) delivered by facemask (50%) or with conventional oxygen therapy (47%), although the difference was not statistically significant. These results could be potentially explained by the physiological benefits provided by the NHF. However, one of the surprising findings of this study was that patients randomized to the facemask NIV group had a similar or even poorer outcome than oxygen alone. Interestingly, an observational study showed that in patients receiving facemask NIV for acute hypoxemia delivered tidal volumes were higher than expected (8.1-11.1 ml/kg predicted body weight), suggesting that NIV could potentially cause ventilator-induced lung injury resulting in worsening respiratory failure. We, therefore, plan a crossover physiologic study investigating the hypothesis that compared with NIV the treatment with NHF of patients with acute hypoxemic non-hypercapnic respiratory failure results in a more homogeneous distribution of tidal volume, and hence less ventilator-induced lung injury, as measured by electrical impedance tomography (EIT). Methods: This physiologic study will enroll 20 patients from the ICU at Toronto General Hospital in one year. Adult patients with acute hypoxemic non cardiogenic respiratory failure and PaO2:FiO2 ≤ 300 mmHg, respiratory rate > 25 breaths/minute, PaCO2 ≤ 45 mmHg and absence of clinical history of underlying chronic respiratory failure will be eligible. Patients that received invasive mechanical ventilation for > 48 hours in the same hospital admission, requiring immediate intubation, with hemodynamic instability (systolic arterial pressure < 90 mmHg after optimal fluid therapy), with Glasgow Coma Scale < 12, or contraindications to noninvasive ventilation and tracheostomy, will be excluded. After baseline assessment while receiving oxygen through facemask or nasal prongs, patients will receive in randomly assigned order NHF for 20 minutes and NIV for 20 minutes, in a crossover manner. EIT recordings, diaphragm ultrasound, and collection of blood samples for arterial blood gases will be performed at the end of each phase. Data analysis: The primary endpoint is the comparison of the EIT intra-tidal ventilation index between treatment with NHF and NIV. As secondary endpoints, we will determine whether NHF, in comparison to NIV, provides respiratory support with lower global inhomogeneity index (EIT), lower tidal volumes, reduces respiratory muscle effort (respiratory rate and diaphragmatic ultrasound), and improves gas exchange (oxygen saturation, PaO2:FiO2, PaCO2, RR).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoxemia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High-Flow Nasal Cannula
    Arm Type
    Experimental
    Arm Title
    Noninvasive ventilation
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Optiflow (High-flow Nasal Cannula)
    Other Intervention Name(s)
    Optiflow
    Intervention Description
    Optiflow will be applied for 20 minutes
    Intervention Type
    Device
    Intervention Name(s)
    Non-invasive Ventilation
    Intervention Description
    non-invasive ventilation will be applied for 20 minutes
    Primary Outcome Measure Information:
    Title
    the intra-tidal ventilation heterogeneity index
    Description
    the intra-tidal ventilation heterogeneity index (VtHit) assessed by electrical impedance tomography (EIT)
    Time Frame
    2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hypoxemia defined by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2:FiO2) ≤ 300 while the patient is breathing oxygen through NHF for at least 15 minutes; Respiratory rate > 25 breaths/minute; Partial pressure of arterial carbon dioxide (PaCO2) ≤ 45 mmHg; Absence of clinical history of underlying chronic respiratory failure. Exclusion Criteria: Lack of consent; Age < 18 years; Invasive mechanical ventilation for > 48 hours in the same hospital admission Immediate need for intubation; Previous inclusion in the present study; Systolic arterial pressure < 90 mmHg after optimal fluid therapy; Cardiogenic pulmonary edema; Glasgow Coma Scale < 12; Imminent death; Contraindications to noninvasive ventilation; Tracheostomy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    L:orenzo Del Sorbo, MD
    Phone
    416-340-4800
    Ext
    8009
    Email
    lorenzo.delsorbo@uhn.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Felicity Backhouse, MSc
    Phone
    416-340-4800
    Ext
    6056
    Email
    felicity.backhouse@uhn.ca

    12. IPD Sharing Statement

    Learn more about this trial

    Therapy With High-flow Oxygen by Nasal Cannula vs Noninvasive Ventilation in Patients With Acute Hypoxemic Respiratory Failure: a Crossover Physiologic Study

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