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

NCT03696563 | Unknown

• 1 other identifier: 20180570-01H
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

COPD Exacerbation; Trauma

Keywords

prehospital; oxygen therapy; automation; trauma; COPD

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (11)

• Oxygenation - Total Time in the target zone SpO2

  Day 1 - During prehospital transportation (from entry in the ambulance until exit of 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 with hypoxemia

  Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)

• 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

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Other: Standard administration of oxygen flow

FreeO2 group

EXPERIMENTAL

The adjustment of the oxygen flow will be made by the FreeO2 system, an automated titration to reach the SpO2 target set by paramedic.

Device: Automated oxygen administration - FreeO2

Interventions

Automated oxygen administration - FreeO2 DEVICE

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.

FreeO2 group

Standard administration of oxygen flow OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• François Lellouche: lead
• The Ottawa Hospital: collaborator
• Ottawa Hospital Research Institute: collaborator

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MeSH Terms

Conditions

Wounds and Injuries; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Austin

  Regional Paramedic Program for Eastern Ontario, Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Austin

CONTACT

613-737-7228; maustin@toh.ca

François Lellouche

CONTACT

418-656-8711; francois.lellouche@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor

Model Details: This will be a single centered prehospital multi-period cluster crossover feasibility trial

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: October 4, 2018
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share