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Clinical Evaluation of FreeO2 (Version 4) in All Patients Receiving Oxygen (FreeO24G)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119727
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
François Lellouche, Laval University

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

Condition or disease Intervention/treatment Phase
Respiratory Disease Respiratory Failure COPD Exacerbation Asthma Pneumonia Device: FreeO2 Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Evaluation of the Automatic Oxygen Adjustment by FreeO2 in a Medical Population in Hospital
Actual Study Start Date : January 30, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Automated oxygen adjustment
All patient in this study have automatic oxygen titration and automatic oxygen weanning
Device: FreeO2
All include patients will have automatic administration of oxygen by FreeO2 up to 3 day or until weaning of oxygen adminisatrion




Primary Outcome Measures :
  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 Outcome Measures :
  1. Oxygenation data [ Time Frame: 3 hospitalisations day or until Oxygen weaning ]

    the % of time with hyperoxia (SpO2 >= SpO2 target+4%), 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119727


Contacts
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Contact: François Lellouche 4186568711 ext 4186568711 francois.lellouche@criucpq.ulaval.ca
Contact: Pierre-alexandre Bouchard 4186568711 ext 2712 pierre-alexandre.bouchard@criucpq.ulaval.ca

Locations
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Canada
IUCPQ-UL Recruiting
Quebec, Canada, G1V4G5
Contact: Pierre-alexandre Bouchard       pierre-alexandre.bouchard@criucpq.ulaval.ca   
Principal Investigator: François Lellouche         
Sponsors and Collaborators
Laval University
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Responsible Party: François Lellouche, Principal Investigator, Laval University
ClinicalTrials.gov Identifier: NCT03119727    
Other Study ID Numbers: 21342
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Respiratory Tract Infections