Prehospital High-Flow Nasal Oxygen Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-21

Study Completion Date

2022-08-10

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

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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.

Conditions

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Acute Respiratory Failure With Hypoxia Oxygen Inhalation Therapy Prehospital Setting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard oxygen therapy

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%

Group Type ACTIVE_COMPARATOR

Standard oxygen therapy

Intervention Type DEVICE

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

High-flow nasal oxygen (HFNO)

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%.

Group Type EXPERIMENTAL

High-flow nasal oxygen

Intervention Type DEVICE

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

Interventions

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High-flow nasal oxygen

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

Intervention Type DEVICE

Standard oxygen therapy

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No