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
About this trial
This is an interventional diagnostic trial for Hypoxemia
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.
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
NCT ID
NCT03865056
First Posted
March 5, 2019
Last Updated
March 5, 2019
Sponsor
University Health Network, Toronto
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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