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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
François Lellouche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation focused on measuring prehospital, oxygen therapy, automation, trauma, COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

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

    First Posted
    December 18, 2017
    Last Updated
    November 6, 2020
    Sponsor
    François Lellouche
    Collaborators
    The Ottawa Hospital, Ottawa Hospital Research Institute
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    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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