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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03119727

Acronym

FreeO24G

Enrollment

Registered

2017-04-19

Start date

2017-01-30

Completion date

2020-11-06

Last updated

2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, COPD Exacerbation, Pneumonia, Respiratory Disease, Respiratory Failure

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)

Interventions

DEVICEFreeO2

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
% 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

Measure	Time frame	Description
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026