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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03119727
Other study ID # 21342
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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