NCT03326830

Prehospital High-Flow Nasal Oxygen Therapy

Prehospital High-Flow Nasal Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: A Randomized, Open-label, Bi-center, Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Acute Respiratory Failure With Hypoxia
• Oxygen Inhalation Therapy
• Prehospital Setting

Interventions

Type	Name	Description
DEVICE	High-flow nasal oxygen	oxygen therapy will be delivered through a dedicated system, the Airvo2™ (Fisher\&Paykel, New-Zealand).
DEVICE	Standard oxygen therapy	Oxygen therapy will be delivered using standard devices such as nasal canula or face mask with or without rebreathing bag

Timeline

• Start date: 2017-12-21
• Primary completion: 2022-08-10
• Completion: 2022-08-10
• First posted: 2017-10-31
• Last updated: 2023-02-17

Locations

2 sites across 1 country: France