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

Asthma Clinical Trial

— FreeO24G  

Official title:

Clinical Evaluation of the Automatic Oxygen Adjustment by FreeO2 in a Medical Population in Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119727
• Other study ID #: 21342
• Status: Completed
• Phase: N/A
• Start date: January 30, 2017
• Est. completion date: November 6, 2020

Study information

• Verified date: June 2024
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 6, 2020
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• COPD Exacerbation
• Pneumonia
• Respiration Disorders
• Respiratory Disease
• Respiratory Failure
• Respiratory Insufficiency
• Respiratory Tract Diseases

Intervention

Device:
• FreeO2
All include patients will have automatic administration of oxygen by FreeO2 up to 3 day or until weaning of oxygen adminisatrion

Locations

Country	Name	City	State
Canada	IUCPQ-UL	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of time in the set SpO2 target	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)	During 3 days of hospitalization or until Oxygen weaning
Secondary	Oxygenation data	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	3 hospitalisations day or until Oxygen weaning