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

François Lellouche

Status: Unknown

Conditions: Trauma; COPD Exacerbation

Treatments: Device: Automated oxygen administration - FreeO2; Other: Standard administration of oxygen flow

Study type: Interventional

Funder types: Other

Identifiers

NCT03696563

20180570-01H

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

COPD patient:

1. Known or suspected acute exacerbation of COPD. Acute exacerbation is defined by worsening of the respiratory condition for less than 2 weeks. Suspected COPD is defined by patients of at least 30 years old with respiratory symptoms with a past or current smoking history of at least 10 pack years, or
2. Able to measure SpO2 via pulse oximetry

Trauma patient:

I) Trauma: patients who sustain any trauma (minor or major), II) Able to measure SpO2 via pulse oximetry

Exclusion criteria

• Inclusion in another study not allowing the co-enrollment
• Pregnancy
• Age <18 years
• Prehospital Invasive or non-invasive mechanical ventilation
• Meeting high concentration oxygen administration injury or condition (as per BLS-PCS Oxygen Therapy Standard (Version 3.0), s(2)a-f).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control group

Active Comparator group

Description:

In this group, the - usual care based upon BLS-PCS with manual titration of oxygen. In this group the SpO2 was recorded any time with FreeO2 device - recording mode.

Treatment:

Other: Standard administration of oxygen flow

FreeO2 group

Experimental group

Description:

The adjustment of the oxygen flow will be made by the FreeO2 system, an automated titration to reach the SpO2 target set by paramedic.

Treatment:

Device: Automated oxygen administration - FreeO2