NCT02599246

Brief Summary

The purpose of this study is to compare pharyngeal FiO2 in day time with nasal normobaric O2 with inhaled FiO2 in the night time with home care ventilator NIV at the same O2 flow.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

November 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

November 17, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2016

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

November 2, 2015

Last Update Submit

January 31, 2017

Conditions

COPDHome CareOxygen Therapy

Keywords

Home ventilatorFiO2O2NIVCOPD

Outcome Measures

Primary Outcomes (1)

  • Difference in FiO2 measured during NIV compared to the FiO2 measured during day time with nasal canula at similar O2 flow

    18 hours

Secondary Outcomes (2)

  • Time spent below different O2 levels during NIV despite constant O2 flow and their correlation to day time FiO2 with nasal canula

    18 hours

  • levels of O2 adjustment needed to keep FiO2 stable with NIV

    1 hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic obstructive pulmonary disease. With day time oxygenotherapy and nocturnal NIV and O2 supply

You may qualify if:

  • informed consent

You may not qualify if:

  • acute on chronic respiratory distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military teaching hospital Ste Anne

Toulon, VAR, 83000, France

Location

Related Publications (1)

  • Cardinale M, Cungi PJ, Esnault P, Castagna O, Nguyen C, Daranda E, Bordes J, Arnal JM, Meaudre E, Goutorbe P. In COPD, Nocturnal Noninvasive Ventilation Reduces the FIO2 Delivered Compared With Long-Term Oxygen Therapy at the Same Flow. Respir Care. 2020 Dec;65(12):1897-1903. doi: 10.4187/respcare.07570. Epub 2020 Jul 21.

    PMID: 32694183DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Philippe GOUTORBE, MD

    Military teaching hospital Ste ANNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 6, 2015

Study Start

November 17, 2015

Primary Completion

February 22, 2016

Study Completion

February 24, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

FR(1)