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Completed

NCT Number: NCT03119727

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

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

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Key information

Conditions

Respiratory Disease Asthma Bronchial Diseases COPD Exacerbation Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Pneumonia Respiration Disorders Respiratory Failure Respiratory Hypersensitivity Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IUCPQ-UL

Québec, Quebec, G1V4G5, Canada

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FreeO2

Device

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

Primary outcomes

  1. % of time in the set SpO2 target

    Time frame: 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 outcomes

  1. Oxygenation data

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Acronym: FreeO24G

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Apr 19, 2017
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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