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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02599246
Other study ID # NIVLEAKS1
Secondary ID
Status Completed
Phase N/A
First received November 2, 2015
Last updated January 31, 2017
Start date November 17, 2015
Est. completion date February 24, 2016

Study information

Verified date January 2017
Source Breas Medical S.A.R.L.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

in a prospective observational study the investigators will register FiO2 in 15 voluntaries COPD patients as following:

- Pharyngeal FiO2 (G5® Philips™ side stream FiO2) with O2 supply through nasal cannula at basal flow (flow needed by patient). In order to compare FiO2s the investigators will measure FiO2 with 150%, 75%, 50% and 25 % of basal Flow

- And FiO2 during nocturnal NIV (pressure support ventilation; Vivo 50®, Bréas™), using facial or nasal masque (Confort Gel® Respironics™). O2 flow will be basal flow.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date February 24, 2016
Est. primary completion date February 22, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- informed consent

Exclusion Criteria:

- acute on chronic respiratory distress

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Military teaching hospital Ste Anne Toulon VAR

Sponsors (1)

Lead Sponsor Collaborator
Breas Medical S.A.R.L.

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in FiO2 measured during NIV compared to the FiO2 measured during day time with nasal canula at similar O2 flow 18 hours
Secondary Time spent below different O2 levels during NIV despite constant O2 flow and their correlation to day time FiO2 with nasal canula 18 hours
Secondary levels of O2 adjustment needed to keep FiO2 stable with NIV 1 hour
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