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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

François Lellouche，Laval University

Tracking Information

First Submitted Date ^ICMJE

December 18, 2017

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Feasibility of the study design - REB approval[ Time Frame: 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 - initiate the clinical trial[ Time Frame: Target until 3 months (90 days) from REB approval ]

Time to readiness to initiate the clinical trial

Feasibility of the study design - Evaluation of data collection tool[ Time Frame: through study completion, average 28 days ]

target: 100% of data captured in >90% cases

Feasibility of the study design - study protocol compliance[ Time Frame: through study completion, average 28 days ]

Target of 80% of compliance for protocol intervention/control group

Feasibility of the study design - Paramedics survey[ Time Frame: through study completion, average 28 days ]

A survey will be complete by Paramedics at the end of day of transportation (day 1); the target response rate is 75% of case.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Oxygenation - Total Time in the target zone SpO2[ Time Frame: 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%)
Oxygenation - Total time with hyperoxia[ Time Frame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance) ]
Percentage of time spent in thyperoxia (SpO2 > 94% in COPD patients and SpO2 >98% in trauma patients)
Oxygenation - Total time with hypoxemia[ Time Frame: 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)
The oxygentherapy complication- PaCO2[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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
Outcome data - NIV[ Time Frame: During hospital stay - approximately 28 days - admission day until hospital discharge ]
The rate of NIV use during lenght of stay in hospital
Outcome data - ICU admission[ Time Frame: During hospital stay- approximately 28 days - admission day until hospital discharge ]
The rate of ICU admission during lenght of stay in hospital
Outcome data - Death[ Time Frame: During hospital stay - hospital admission through study completion average 28 days or until death if occured ]
The rate of death during lenght of stay in hospital
Outcome data[ Time Frame: Length of hospital stay measured in calendar days, hospital admission through study completion, average 28 days ]
Duration of the hospital length of stay
The oxygen consumption during the pre-hospital transport[ Time Frame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance), ]
Mean O2 flow rate (total O2 consumption) during transportation

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Automated Administration of Oxygen (FreeO2) in Ambulances for COPD and Trauma Patients

Brief Summary

Evaluation of automated oxygen titration in comparison with manual adjustment in ambulance.

Detailed Description

It's a single center study in Canada. This will be a single centred prehospital multi-period cluster crossover feasibility trial, (see Figure 2a) 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 centred 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 the arrival of the vehicle to a hospital. Each patient will be randomized into one of two groups according to the usual oxygen therapy or oxygen therapy protocol with the automated system FreeO2. In both groups, SpO2 will be collected continuously every second FreeO2 monitoring, in addition to the collection of vital signs carried out by the staff according to the standards.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a single centred prehospital multi-period cluster crossover feasibility trial
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

Other: Control group
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: FreeO2 group
The adjustment of the oxygen flow will be made by the FreeO2 system, an automated titration to reach the SpO2 target set by clinician.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2019

Estimated Primary Completion Date

December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

François Lellouche，Laval University

Study Sponsor ^ICMJE

Laval University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Michael Austin the ottawa general hospital

PRS Account

Laval University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名