NCT03119727

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2020

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

April 12, 2017

Last Update Submit

June 17, 2024

Conditions

Respiratory DiseaseRespiratory FailureCOPD ExacerbationAsthmaPneumonia

Outcome Measures

Primary Outcomes (1)

  • % 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)

    During 3 days of hospitalization or until Oxygen weaning

Secondary Outcomes (1)

  • Oxygenation data

    3 hospitalisations day or until Oxygen weaning

Study Arms (1)

Automated oxygen adjustment

OTHER

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

Device: FreeO2

Interventions

FreeO2DEVICE

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

Automated oxygen adjustment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IUCPQ-UL

Québec, Quebec, G1V4G5, Canada

Location

MeSH Terms

Conditions

Respiration DisordersRespiratory InsufficiencyAsthmaPneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 19, 2017

Study Start

January 30, 2017

Primary Completion

April 30, 2019

Study Completion

November 6, 2020

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations

CA(1)