Prehospital High-Flow Nasal Oxygen Therapy

Centre Hospitalier Régional d'Orléans58 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Respiratory Failure With Hypoxia Oxygen Inhalation Therapy Prehospital Setting

Interventions

High-flow nasal oxygenDEVICE

oxygen therapy will be delivered through a dedicated system, the Airvo2™ (Fisher\&Paykel, New-Zealand).

Standard oxygen therapyDEVICE

Oxygen therapy will be delivered using standard devices such as nasal canula or face mask with or without rebreathing bag

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

CHR d'ORLEANS

Orléans, France

Brigade des Sapeurs Pompiers de Paris

Paris, France

Outcomes

Primary Outcomes

need of mechanical ventilation

cumulative incidence of the use of tracheal intubation or noninvasive ventilation (whichever comes first) from enrolment to day 28

Time frame: 28 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 1 hour

Survival

Probability of survival from inclusion to day 28

Time frame: 28 days

SpO2

Time course of SpO2

Time frame: 1 hour

Respiratory rate

Time course of respiratory rate

Time frame: 1 hour

Heart rate

Time course of heart rate

Time frame: 1 hour

Tracheal intubation

Cumulative incidence of tracheal intubation from inclusion to day 28.

Time frame: 28 days

Data from ClinicalTrials.gov

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