Clinical Evaluation of FreeO2 (Version 4) in All Patients Receiving Oxygen

Not Applicable

Completed

• Conditions: COPD Exacerbation; Asthma; Respiratory Failure; Pneumonia; Respiratory Disease
• Interventions: Device: FreeO2

• Registration Number: NCT03119727
• Lead Sponsor: Laval University

Brief Summary

Evaluation of automatic titration of oxygen with a new version of FreeO2 (V4)

Detailed Description

In the previous studies, the investigators used many times automatic titration of oxygen on spontanous breathing patient (FreeO2 device) with a prototype develop in our lab in collaboration with Laval university. In this study, we want to evaluate the new version of the FreeO2 device (V4)

Study Timeline

• Study Start: 2017-01-30
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-19
• Primary Completion: 2019-04-30
• Study Completion: 2020-11-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age > or = 18 years old
• Patient receiving oxygen between 1 to 6 lpm for medical pathology
• Admitted to a medical service for less than 72 hours (emergency room not included)

Exclusion Criteria

• Unreliable SpO2 signal
• Emergency or intensive care hospitalization
• Absence of NIV or intubation criteria at baseline
• Sleep apnea not paired
• Long-term Oxygen Therapy
• Active delirium and cognitive impairment preventing informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Automated oxygen adjustment	FreeO2	All patient in this study have automatic oxygen titration and automatic oxygen weanning

Primary Outcome Measures

Name	Time	Method
% of time in the set SpO2 target	During 3 days of hospitalization or until Oxygen weaning	Continuous SpO2 monitoring (1 data each second) will be recorded, the % of time within the SpO2 target±2% set by the physician will be considered (Time in the target±2/Total recording time)

Secondary Outcome Measures

Name	Time	Method
Oxygenation data	3 hospitalisations day or until Oxygen weaning	the % of time with hyperoxia (SpO2 \> SpO2 target+5%), the % of time with severe hypoxemia (SpO2 \<85%) the % of time without SpO2 signal, the % of time with oscillations of SpO2 values, comparison of Wired SpO2 vs Bluetooth SpO2, Daily variations of oxygen flows J1, J2 and J3; % Weaning\> 50% relative baseline,% complete weaning of O2

Trial Locations

Locations (1)

IUCPQ-UL; 🇨🇦 Quebec, Canada