Automated Administration of Oxygen Using the FreeO2 Device in Ambulances for COPD and Trauma Patients: A Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Feasibility of the study design - Paramedics survey
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
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.
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
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
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
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
Secondary Outcomes
- The oxygentherapy complication- PaCO2(Day 1- On The first ABG or capillary blood gases after hospital admission)
- The oxygentherapy complication - respiratory acidosis(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(Day 1 - At the end of the transportation (at the exit from the ambulance))
- Oxygenation - Total time with hyperoxia(Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance))
- Oxygenation - Total Time in the target zone SpO2(Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance))
- Outcome data - NIV(through study completion, an average of 1 year)
- Outcome data(Length of hospital stay measured in calendar days, hospital admission through study completion, up to 8 weeks)
- Oxygenation - Total time with hypoxemia(Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance))
- Outcome data - Death(During hospital stay - hospital admission through study completion or until death if occured, up to 8 weeks)
- Outcome data - ICU admission(through study completion, an average of 1 year)
- The oxygen consumption during the pre-hospital transport(Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance),)
Investigators
François Lellouche
Sponsor
Laval University