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

February 25, 2019 updated by: François Lellouche, Laval University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% 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)
During 3 days of hospitalization or until Oxygen weaning

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 hospitalisations day or until Oxygen weaning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2017

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 19, 2017

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21342

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia

Clinical Trials on FreeO2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe