FiO2 in Chronic Obstructive Pulmonary Disease (COPD) Patient Normobaric O2 Versus NIV

COPD Clinical Trial

— NIVLEAKS  

Official title:

Measured FiO2 With Nasal Canula O2 Versus Noninvasive Ventilation (NIV) With the Same O2 Flow, in COPD Patients the NIV LEAKS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599246
• Other study ID #: NIVLEAKS1
• 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
• 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

Related Conditions & MeSH terms

• COPD
• Home Care
• Oxygen Therapy
• Pulmonary Disease, Chronic Obstructive

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