Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure

Study Overview
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Brief Summary
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Acute hypoxemic respiratory failure may require invasive mechanical ventilation. However, invasive mechanical ventilation is associated with a variety of complications. Non-invasive ventilation has been presented as an alternative treatment but controversy remains. The investigators hypothesize that high-flow nasal cannula system is effective enough to prevent intubation in acute hypoxemic respiratory failure and not inferior to non-invasive ventilation.

Official Title
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Prospective, Open-labeled, Randomized Controlled Trial of Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure

Conditions
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Acute Hypoxemic Respiratory Failure

Intervention / Treatment
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* Device: Non-invasive ventilation
* Device: High flow nasal cannula system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 patients with acute hypoxemic respiratory failure Exclusion Criteria: age < 18 years hypercapnia (arterial carbon dioxide tension (PaCO2) >45mmHg) at admission need for emergency intubation, including cardiopulmonary resuscitation recent esophageal, facial or cranial trauma or surgery severely decreased consciousness (Glasgow coma score <11) cardiogenic shock or severe hemodynamic instability systolic blood pressure <90 mmHg associated with decreased urinary output(<20 mL.h-1) despite fluid repletion and use of vasoactive agents lack of co-operation altered mental status with decreased consciousness and/or evidence of inability to understand or lack of willingness to co-operate with the procedures tracheotomy or other upper airway disorders severe ventricular arrhythmia or active myocardial ischemia active upper gastrointestinal bleeding inability to clear respiratory secretions more than one severe organ dysfunction in addition to respiratory failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-flow nasal cannula<br>In this arm,patients with acute hypoxemic respiratory failure were treated with high-flow nasal cannula system(Optiflow, Fisher & Paykel, Auckland, New Zealand) to achieve SpO2 >92% or PaO2 >65 mmHg. | Device: High flow nasal cannula system<br>* High flow nasal cannula system: FiO2 and flow rate of oxygen is set to achieve SpO2 >92% or PaO2 >65 mmHg.<br>* Other names: Optiflow(Fisher & Paykel, Auckland, New Zealand);|
| Active Comparator: Non-invasive ventilation<br>In this arm, patients with acute hypoxemic respiratory failure is treated with the bi-level positive airways pressure mode (BiPAP Vision, Respironics Inc., Murrysville, PA) S/T mode to achieve SpO2 >92% or PaO2 >65 mmHg. | Device: Non-invasive ventilation<br>* Noninvasive ventilation: The inspiratory(IPAP) and expiratory positive airways pressure (EPAP), and the levels of FiO2 is set achieve SpO2 >92% or PaO2 >65 mmHg.<br>* Other names: (BiPAP Vision, Respironics Inc., Murrysville, PA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of treatment in two groups | Successful treatment is to avoid intubation and achieve PaO2 >75 mmHg without respiratory distress for 24 hours while spontaneously breathing oxygen provided by a Venturi device at FiO2 0.50. | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance of treatment | Withdrawl of non-invasive ventilation or high-flow nasal cannula system without intubation because of intolerance | up to 28 days | 
| adverse event |  | up to 28 days | 
| hospital length of stay |  | up to 90 days | 
| Hospital mortality |  | up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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respiratory failure