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

November 6, 2020 updated by: François Lellouche

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michael Austin
  • Phone Number: 613-737-7228
  • Email: maustin@toh.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
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.
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.
Experimental: FreeO2 group
The adjustment of the oxygen flow will be made by the FreeO2 system, an automated titration to reach the SpO2 target set by paramedic.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the study design - REB approval
Time Frame: Date of REB submission to date of REB approval, target: until 3 months (90 days) from REB submission
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
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 Frame: Target until 3 months (90 days) from REB approval
Time to readiness to initiate the clinical trial
Target until 3 months (90 days) from REB approval
Feasibility of the study design - Evaluation of data collection tool
Time Frame: through study completion, an average of 1 year
target: 100% of data captured in >90% cases
through study completion, an average of 1 year
Feasibility of the study design - study protocol compliance
Time Frame: through study completion,an average of 1 year
Target of 80% of compliance for protocol intervention/control group
through study completion,an average of 1 year
Feasibility of the study design - Paramedics survey
Time Frame: through study completion, an average of 1 year
A survey will be complete by Paramedics at the end of day of transportation (day 1); the target response rate is 75% of case.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation - Total Time in the target zone SpO2
Time Frame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)

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%)
Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
Oxygenation - Total time with hyperoxia
Time Frame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
Percentage of time spent in hyperoxia (SpO2 > 94% in COPD patients and SpO2 >98% in trauma patients)
Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
Oxygenation - Total time with hypoxemia
Time Frame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)

Percentage of time spent in the target zone SpO2

- % of time with hypoxemia (SpO2<86% in COPD patients and SpO2 <90% in trauma patients)
Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
The oxygentherapy complication- PaCO2
Time Frame: Day 1- On The first ABG or capillary blood gases after hospital admission
-Evaluation of level of PaCO2 on the first ABG at ED or ICU admission (when available)
Day 1- On The first ABG or capillary blood gases after hospital admission
The oxygentherapy complication - respiratory acidosis
Time Frame: Day 1- On The first ABG or capillary blood gases after hospital admission
-Evaluation of the rate of respiratory acidosis (pH<7.35 and PaCO2>45mmHg) after hospital admission
Day 1- On The first ABG or capillary blood gases after hospital admission
The rate of patients without oxygen at the end of the transportation
Time Frame: Day 1 - At the end of the transportation (at the exit from the ambulance)
Rate of patient weaned of oxygen at the end of the transportation
Day 1 - At the end of the transportation (at the exit from the ambulance)
Outcome data - NIV
Time Frame: through study completion, an average of 1 year
The rate of NIV use during lenght of stay in hospital
through study completion, an average of 1 year
Outcome data - ICU admission
Time Frame: through study completion, an average of 1 year
The rate of ICU admission during lenght of stay in hospital
through study completion, an average of 1 year
Outcome data - Death
Time Frame: During hospital stay - hospital admission through study completion or until death if occured, up to 8 weeks
The rate of death during lenght of stay in hospital
During hospital stay - hospital admission through study completion or until death if occured, up to 8 weeks
Outcome data
Time Frame: Length of hospital stay measured in calendar days, hospital admission through study completion, up to 8 weeks
Duration of the hospital length of stay
Length of hospital stay measured in calendar days, hospital admission through study completion, up to 8 weeks
The oxygen consumption during the pre-hospital transport
Time Frame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance),
Mean O2 flow rate (total O2 consumption) during transportation
Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance),

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

François Lellouche

Collaborators

Ottawa Hospital Research Institute
The Ottawa Hospital

Investigators

  • Principal Investigator: Michael Austin, Regional Paramedic Program for Eastern Ontario, Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

October 2, 2018

First Posted (Actual)

October 4, 2018

Study Record Updates

Last Update Posted (Actual)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180570-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not plan to share individual participant data. All data if shared with be de-identified. Data will be stored on a secure server with access only by study personal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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