Prehospital High-Flow Nasal Oxygen Therapy (PRHOXY-1)

Centre Hospitalier Régional d'Orléans

Status: Completed

Conditions: Acute Respiratory Failure With Hypoxia; Prehospital Setting; Oxygen Inhalation Therapy

Treatments: Device: Standard oxygen therapy; Device: High-flow nasal oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT03326830

2017-A01922-51 (Other Identifier)

CHRO-2017-09 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Standard oxygen therapy

Active Comparator group

Description:

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%

Treatment:

Device: Standard oxygen therapy

High-flow nasal oxygen (HFNO)

Experimental group

Description:

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%.

Treatment:

Device: High-flow nasal oxygen