Prehospital High-Flow Nasal Oxygen Therapy

Study Overview
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Brief Summary
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The purpose of the present project is to compare High-Flow Nasal Oxygen therapy with Standard Oxygen therapy, initiated in the prehospital setting in patients with acute hypoxemia respiratory failure, in terms of oxygenation at arrival to the hospital and need of mechanical ventilation during the subsequent 28 days

Detailed Description
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Patients with respiratory distress and an SpO2 below 90% in the prehospital setting will be randomized to receive either high-flow nasal oxygen therapy through a dedicated device or standard oxygen therapy through standard devices such as nasal cannula or face mask. Need of mechanical ventilation either invasive or noninvasive from enrollment to day 28 and time course of oxygenation between first SpO2 measured on scene and arrival to the hospital will be the main outcome measures.

Official Title
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Prehospital High-Flow Nasal Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: A Randomized, Open-label, Bi-center, Pilot Study

Conditions
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Acute Respiratory Failure With Hypoxia, Oxygen Inhalation Therapy, Prehospital Setting

Intervention / Treatment
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* Device: High-flow nasal oxygen
* Device: Standard oxygen therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years First SpO2 on scene <90% At least one other sign of respiratory distress defined by (a) respiratory distress with a respiratory rate ≥ 25/min; (b) laboured breathing No advance directives or known decisions of Do Not intubate or Do Not Ventilate order. Exclusion Criteria: Known COPD or other hypercapnic chronic respiratory failure age <18 years Pregnancy or breastfeeding Anatomical factors precluding the use of a nasal cannula Emergency intubation required Patients with tracheostomy Patient transported to a hospital not involved in the study

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
Interventional Model Description: Bi-center, open-label, parallel, randomized trial with 1:2 allocation ratio (2 patients assigned to standard oxygen therapy for 1 patient assigned to High Flow Nasal Oxygen therapy)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard oxygen therapy<br>Standard oxygen therapy will be delivered using any device or combination of devices that are part of usual care: nasal oxygen, and mask with or without a reservoir bag and with or without the Venturi system. The flow will be tapered to target an SpO2 ≥ 95% | Device: Standard oxygen therapy<br>* Oxygen therapy will be delivered using standard devices such as nasal canula or face mask with or without rebreathing bag<br>|
| Experimental: High-flow nasal oxygen (HFNO)<br>Experimental: High-flow nasal oxygen (HFNO) group Device that delivers humidified and warmed high-flow oxygen at flows between 30-60L/min HFNO will be initiated at a flow rate between 30-60 L/min and FiO2 titrated for a target of SpO2 ≥ 95%. | Device: High-flow nasal oxygen<br>* oxygen therapy will be delivered through a dedicated system, the Airvo2™ (Fisher&Paykel, New-Zealand).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need of mechanical ventilation | cumulative incidence of the use of tracheal intubation or noninvasive ventilation (whichever comes first) from enrolment to day 28 | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia | Frequency of hypoxemia, defined as sustained (at least 5 min) SpO2 below 90% (SpO2 will be continuously recorded throughout the prehospital medical care period) from the beginning of the intervention period until arrival at Emergency Department or other hospital ward. | 1 hour | 
| Severe hypoxemia | Frequency of severe hypoxemia, defined as sustained (at least 5 min) SpO2 below 85% from the beginning of the intervention period until arrival at Emergency Department or other hospital ward. | 1 hour | 
| Survival | Probability of survival from inclusion to day 28 | 28 days | 
| SpO2 | Time course of SpO2 | 1 hour | 
| Respiratory rate | Time course of respiratory rate | 1 hour | 
| Heart rate | Time course of heart rate | 1 hour | 
| Tracheal intubation | Cumulative incidence of tracheal intubation from inclusion to day 28. | 28 days | 
| Noninvasive ventilation | Cumulative incidence of noninvasive ventilation use for acute respiratory failure from inclusion to day 28 | 28 days | 
| arterial pH | arterial pH (units) measured at hospital arrival | 1 hour | 
| arterial PaCO2 | arterial PaCO2 (mmHg) measured at hospital arrival | 1 hour | 
| arterial PaO2 | arterial PaO2 (mmHg) measured at hospital arrival | 1 hour | 
| Dyspnea | Dyspnea intensity as assessed by the patient him/herself at hospital arrival using the following dyspnea score: frank improvement: +2; mild improvement: +1; No change: 0; slight worsening: -1; frank worsening:-2. | 1 hour | 
| Serious Adverse Events | The number of serious adverse events during the intervention phase of the study | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Insufficiency, Oxygen Inhalation Therapy