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

Primary Purpose

Respiratory Disease, Respiratory Failure, COPD Exacerbation

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

FreeO2

About this trial

This is an interventional other trial for Respiratory Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

IUCPQ-ULRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Automated oxygen adjustment

Arm Description

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

Outcomes

Primary Outcome Measures

% of time in the set SpO2 target

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

Oxygenation data

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

Full Information

NCT ID

NCT03119727

First Posted

April 12, 2017

Last Updated

February 25, 2019

Sponsor

Laval University

1. Study Identification

Unique Protocol Identification Number

NCT03119727

Brief Title

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

Acronym

FreeO24G

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 30, 2017 (Actual)

Primary Completion Date

June 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Automated oxygen adjustment

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

FreeO2

Intervention Description

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

Primary Outcome Measure Information:

Title

% of time in the set SpO2 target

Description

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)

Time Frame

During 3 days of hospitalization or until Oxygen weaning

Secondary Outcome Measure Information:

Title

Oxygenation data

Description

Time Frame

3 hospitalisations day or until Oxygen weaning

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

François Lellouche

Phone

4186568711

Ext

4186568711

francois.lellouche@criucpq.ulaval.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre-alexandre Bouchard

Phone

4186568711

Ext

2712

pierre-alexandre.bouchard@criucpq.ulaval.ca

Facility Information:

Facility Name

IUCPQ-UL

City

Quebec

ZIP/Postal Code

G1V4G5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre-alexandre Bouchard

pierre-alexandre.bouchard@criucpq.ulaval.ca

First Name & Middle Initial & Last Name & Degree

François Lellouche

12. IPD Sharing Statement

Learn more about this trial

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

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