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

François Lellouche100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

COPD Exacerbation Trauma

Interventions

Automated oxygen administration - FreeO2DEVICE

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.

Standard administration of oxygen flowOTHER

The flow of oxygen will be administered according to the usual protocol during the transport and until transfer to the emergency departement.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Feasibility of the study design - REB approval

Time to REB approval for single site time to REB approval for single site define by below 3 months (90 days) from REB submission, time to readiness to initiate the clinical trial after REB approval - below 3 months (90 days) from REB approval, evaluation of data collection tool - 100% of data captured in \>90% case at hospital discharge (until day 28), Survey responses from Paramedics - At the end of the transportation day

Time frame: Date of REB submission to date of REB approval, target: until 3 months (90 days) from REB submission

Feasibility of the study design - initiate the clinical trial

Time to readiness to initiate the clinical trial

Time frame: Target until 3 months (90 days) from REB approval

Feasibility of the study design - Evaluation of data collection tool

target: 100% of data captured in \>90% cases

Time frame: through study completion, an average of 1 year

Feasibility of the study design - study protocol compliance

Target of 80% of compliance for protocol intervention/control group

Time frame: through study completion,an average of 1 year

Feasibility of the study design - Paramedics survey

A survey will be complete by Paramedics at the end of day of transportation (day 1); the target response rate is 75% of case.

Time frame: through study completion, an average of 1 year

Secondary Outcomes

Oxygenation - Total Time in the target zone SpO2

Percentage of time spent in the target zone SpO2 * 90±2% in the COPD population (in the range of 88 to 92%) * 94±2% in the trauma population (in the range of 92 to 96%)

Central Contacts

Michael Austin

CONTACT

613-737-7228 maustin@toh.ca

François Lellouche

CONTACT

418-656-8711 francois.lellouche@criucpq.ulaval.ca

Data from ClinicalTrials.gov

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