FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
Primary Purpose
COPD Exacerbation, Trauma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Automated oxygen administration - FreeO2
Standard administration of oxygen flow
Sponsored by
About this trial
This is an interventional treatment trial for COPD Exacerbation focused on measuring prehospital, oxygen therapy, automation, trauma, COPD
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
FreeO2 group
Arm 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.
The adjustment of the oxygen flow will be made by the FreeO2 system, an automated titration to reach the SpO2 target set by paramedic.
Outcomes
Primary Outcome Measures
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
Feasibility of the study design - initiate the clinical trial
Time to readiness to initiate the clinical trial
Feasibility of the study design - Evaluation of data collection tool
target: 100% of data captured in >90% cases
Feasibility of the study design - study protocol compliance
Target of 80% of compliance for protocol intervention/control group
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.
Secondary Outcome Measures
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%)
Oxygenation - Total time with hyperoxia
Percentage of time spent in hyperoxia (SpO2 > 94% in COPD patients and SpO2 >98% in trauma patients)
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)
The oxygentherapy complication- PaCO2
-Evaluation of level of PaCO2 on the first ABG at ED or ICU admission (when available)
The oxygentherapy complication - respiratory acidosis
-Evaluation of the rate of respiratory acidosis (pH<7.35 and PaCO2>45mmHg) 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
Outcome data - NIV
The rate of NIV use during lenght of stay in hospital
Outcome data - ICU admission
The rate of ICU admission during lenght of stay in hospital
Outcome data - Death
The rate of death during lenght of stay in hospital
Outcome data
Duration of the hospital length of stay
The oxygen consumption during the pre-hospital transport
Mean O2 flow rate (total O2 consumption) during transportation
Full Information
NCT ID
NCT03696563
First Posted
December 18, 2017
Last Updated
November 6, 2020
Sponsor
François Lellouche
Collaborators
The Ottawa Hospital, Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03696563
Brief Title
FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
Official Title
Automated Administration of Oxygen Using the FreeO2 Device in Ambulances for COPD and Trauma Patients: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
François Lellouche
Collaborators
The Ottawa Hospital, Ottawa Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation, Trauma
Keywords
prehospital, oxygen therapy, automation, trauma, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This will be a single centered prehospital multi-period cluster crossover feasibility trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm 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.
Arm Title
FreeO2 group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Automated oxygen administration - FreeO2
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard administration of oxygen flow
Intervention Description
The flow of oxygen will be administered according to the usual protocol during the transport and until transfer to the emergency departement.
Primary Outcome Measure Information:
Title
Feasibility of the study design - REB approval
Description
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
Title
Feasibility of the study design - initiate the clinical trial
Description
Time to readiness to initiate the clinical trial
Time Frame
Target until 3 months (90 days) from REB approval
Title
Feasibility of the study design - Evaluation of data collection tool
Description
target: 100% of data captured in >90% cases
Time Frame
through study completion, an average of 1 year
Title
Feasibility of the study design - study protocol compliance
Description
Target of 80% of compliance for protocol intervention/control group
Time Frame
through study completion,an average of 1 year
Title
Feasibility of the study design - Paramedics survey
Description
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 Outcome Measure Information:
Title
Oxygenation - Total Time in the target zone SpO2
Description
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%)
Time Frame
Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
Title
Oxygenation - Total time with hyperoxia
Description
Percentage of time spent in hyperoxia (SpO2 > 94% in COPD patients and SpO2 >98% in trauma patients)
Time Frame
Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
Title
Oxygenation - Total time with hypoxemia
Description
Percentage of time spent in the target zone SpO2
- % of time with hypoxemia (SpO2<86% in COPD patients and SpO2 <90% in trauma patients)
Time Frame
Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
Title
The oxygentherapy complication- PaCO2
Description
-Evaluation of level of PaCO2 on the first ABG at ED or ICU admission (when available)
Time Frame
Day 1- On The first ABG or capillary blood gases after hospital admission
Title
The oxygentherapy complication - respiratory acidosis
Description
-Evaluation of the rate of respiratory acidosis (pH<7.35 and PaCO2>45mmHg) after hospital admission
Time Frame
Day 1- On The first ABG or capillary blood gases after hospital admission
Title
The rate of patients without oxygen at the end of the transportation
Description
Rate of patient weaned of oxygen at the end of the transportation
Time Frame
Day 1 - At the end of the transportation (at the exit from the ambulance)
Title
Outcome data - NIV
Description
The rate of NIV use during lenght of stay in hospital
Time Frame
through study completion, an average of 1 year
Title
Outcome data - ICU admission
Description
The rate of ICU admission during lenght of stay in hospital
Time Frame
through study completion, an average of 1 year
Title
Outcome data - Death
Description
The rate of death during lenght of stay in hospital
Time Frame
During hospital stay - hospital admission through study completion or until death if occured, up to 8 weeks
Title
Outcome data
Description
Duration of the hospital length of stay
Time Frame
Length of hospital stay measured in calendar days, hospital admission through study completion, up to 8 weeks
Title
The oxygen consumption during the pre-hospital transport
Description
Mean O2 flow rate (total O2 consumption) during transportation
Time Frame
Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance),
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Austin
Phone
613-737-7228
Email
maustin@toh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
François Lellouche
Phone
418-656-8711
Email
francois.lellouche@criucpq.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Austin
Organizational Affiliation
Regional Paramedic Program for Eastern Ontario, Ottawa Hospital Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
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FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
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