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

Not Applicable

Completed

• Conditions: Acute Respiratory Failure
• Interventions: Device: Standard oxygen; Device: High-flow oxygen

• Registration Number: NCT03447457
• Lead Sponsor: Poitiers University Hospital

Brief Summary

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

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%.

Study Timeline

• Study Start: 2015-12-01
• Primary Completion: 2017-05-30
• Study Completion: 2017-05-30
• Status Verified: 2018-02
• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-02-26
• Last Update Submitted: 2018-02-26
• Study First Posted: 2018-02-27
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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,

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
standard oxygen group	Standard oxygen	Patients are treated with standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir
High-flow oxygen group	High-flow oxygen	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

Primary Outcome Measures

Name	Time	Method
complete regression of respiratory failure	one hour after initiation of oxygen strategies	respiratory rate less than 25 breaths per minute and regression of signs of increased work of breathing

Trial Locations

Locations (2)

CHG de Niort; 🇫🇷 Niort, France

CHU Poitiers; 🇫🇷 Poitiers, France