FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
- Conditions
- TraumaCOPD Exacerbation
- Interventions
- Other: Standard administration of oxygen flowDevice: Automated oxygen administration - FreeO2
- Registration Number
- NCT03696563
- Lead Sponsor
- François Lellouche
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Control group Standard administration of oxygen flow 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. FreeO2 group Automated oxygen administration - FreeO2 The adjustment of the oxygen flow will be made by the FreeO2 system, an automated titration to reach the SpO2 target set by paramedic.
- Primary Outcome Measures
Name Time Method Feasibility of the study design - Paramedics survey 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 through study completion, an average of 1 year target: 100% of data captured in \>90% cases
Feasibility of the study design - initiate the clinical trial Target until 3 months (90 days) from REB approval Time to readiness to initiate the clinical trial
Feasibility of the study design - REB approval 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 - study protocol compliance through study completion,an average of 1 year Target of 80% of compliance for protocol intervention/control group
- Secondary Outcome Measures
Name Time Method The oxygentherapy complication- PaCO2 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)
The oxygentherapy complication - respiratory acidosis 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
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) Rate of patient weaned of oxygen at the end of the transportation
Oxygenation - Total time with hyperoxia 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)
Oxygenation - Total Time in the target zone SpO2 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%)Outcome data - NIV through study completion, an average of 1 year The rate of NIV use during lenght of stay in hospital
Outcome data Length of hospital stay measured in calendar days, hospital admission through study completion, up to 8 weeks Duration of the hospital length of stay
Outcome data - ICU admission through study completion, an average of 1 year The rate of ICU admission during lenght of stay in hospital
Oxygenation - Total time with hypoxemia 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)Outcome data - Death 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
The oxygen consumption during the pre-hospital transport Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance), Mean O2 flow rate (total O2 consumption) during transportation