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

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

Detailed Description
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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.

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

Conditions
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COPD Exacerbation, Trauma

Intervention / Treatment
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* Device: Automated oxygen administration - FreeO2
* Other: Standard administration of oxygen flow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD patient: 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 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This will be a single centered prehospital multi-period cluster crossover feasibility trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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<br>* The flow of oxygen will be administered according to the usual protocol during the transport and until transfer to the emergency departement.<br>|
| Experimental: FreeO2 group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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 | -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 | -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 | 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 | The rate of NIV use during lenght of stay in hospital | through study completion, an average of 1 year | 
| Outcome data - ICU admission | The rate of ICU admission during lenght of stay in hospital | through study completion, an average of 1 year | 
| Outcome data - Death | 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 | 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 | Mean O2 flow rate (total O2 consumption) during transportation | Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance), | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prehospital, oxygen therapy, automation, trauma, COPD