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

NCT ID: NCT03119727

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2020-11-06

Brief Summary

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

Detailed Description

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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)

Conditions

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Respiratory Disease Respiratory Failure COPD Exacerbation Asthma Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Automated oxygen adjustment

All patient in this study have automatic oxygen titration and automatic oxygen weanning

Group Type OTHER

FreeO2

Intervention Type DEVICE

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

Interventions

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FreeO2

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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François Lellouche

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IUCPQ-UL

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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21342

Identifier Type: -

Identifier Source: org_study_id

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