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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03696563
• Other study ID #: 20180570-01H
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: June 2022

Study information

• Verified date: November 2020
• Source: Laval University
• Contact: Michael Austin
• Phone: 613-737-7228
• Email: maustin[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COPD Exacerbation
• Trauma
• Wounds and Injuries

Intervention

Device:
• Automated oxygen administration - FreeO2
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.

Other:
• Standard administration of oxygen flow
The flow of oxygen will be administered according to the usual protocol during the transport and until transfer to the emergency departement.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
François Lellouche	Ottawa Hospital Research Institute, The Ottawa Hospital

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	Outcome data - NIV	The rate of NIV use during lenght of stay in hospital	through study completion, an average of 1 year
Secondary	Outcome data - ICU admission	The rate of ICU admission during lenght of stay in hospital	through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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),