Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study

Study Overview
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Brief Summary
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The aim of the study is to compare the efficiency on respiratory failure regression of high-flow nasal oxygen therapy versus standard oxygen in patients admitted to the ED for de novo acute respiratory failure.

Detailed Description
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Prospective observational before-after study at the ED in two French centers. Selection of patients with acute hypoxemic respiratory failure at the ED. Application of oxygen strategy according to the period: before period: standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir mask, with a flow rate adjusted to maintain a pulse oxymetry of at least 92%. after period: high-flow oxygen therapy continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min and a FiO2 adjusted to maintain a pulse oxymetry at least 92%.

Official Title
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Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study

Conditions
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Acute Respiratory Failure

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: de novo acute respiratory failure cowith the following criteria: a respiratory rate > 25 b/min, or signs of increased work of breathing. Main exclusion Criteria: cardiogenic pulmonary edema, acute exacerbation of chronic lung disease, respiratory acidosis (pH < 7.35 and PaCO2 > 50 mm Hg), hemodynamic instability Glasgow Coma Scale score of 12 points or less, an urgent need for endotracheal intubation,

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: FLORAL-ER is a before/after study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: standard oxygen group<br>Patients are treated with standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir | Device: Standard oxygen<br>* nasal cannula, face mask or non-rebreathing reservoir mask<br>|
| Other: High-flow oxygen group<br>Patients are treated with high-flow nasal cannula oxygen continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min | Device: High-flow oxygen<br>* HFNC is continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min and a FiO2 adjusted to maintain a pulse oxymetry at least 92%<br>* Other names: High-flow nasal cannula oxygen therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete regression of respiratory failure | respiratory rate less than 25 breaths per minute and regression of signs of increased work of breathing | one hour after initiation of oxygen strategies |