NCT03696563

FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS

Automated Administration of Oxygen Using the FreeO2 Device in Ambulances for COPD and Trauma Patients: A Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: François Lellouche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of automated oxygen titration in comparison with manual adjustment oxygen in the out-of-hospital setting by paramedics.

Detailed description

It is a single center study in Ottawa, Ontario Canada. This will be a single centered prehospital multi-period cluster crossover feasibility trial, enrolling patients in Ottawa, Ontario, who are treated by paramedics from the Ottawa Paramedic Service, who have been trained in the use of the automated oxygen delivery device. We will be using the FreeO2 device. Patients requiring oxygen therapy during prehospital transportation will be enrolled. No randomization will occur within this single centered feasibility study Patients requiring oxygen therapy during the prehospital transportation will be enrolled and will be included as soon as they are placed into the ambulance, until handover and transfer of care at receiving hospital. In both groups, SpO2 will be collected continuously every second with FreeO2 monitoring, in addition to the collection of vital signs carried out by the staff according to the standards.

Conditions

• COPD Exacerbation
• Trauma

Interventions

Type	Name	Description
DEVICE	Automated oxygen administration - FreeO2	The adjustment of the oxygen flow will be made by the FreeO2 system, an automated titration of oxygen flow every second to reach the SpO2 target. The SpO2 target will be set at 90% in COPD patients and 94% in trauma patients.
OTHER	Standard administration of oxygen flow	The flow of oxygen will be administered according to the usual protocol during the transport and until transfer to the emergency departement.

Timeline

• Start date: 2021-09-01
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2018-10-04
• Last updated: 2020-11-12