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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02599246
Acronym
NIVLEAKS
Enrollment
14
Registered
2015-11-06
Start date
2015-11-17
Completion date
2016-02-24
Last updated
2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Home Care, Oxygen Therapy

Keywords

Home ventilator, FiO2, O2, NIV, COPD

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.

Detailed 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.

Interventions

None listed

Sponsors

Breas Medical S.A.R.L.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* informed consent

Exclusion criteria

* acute on chronic respiratory distress

Design outcomes

Primary

MeasureTime frame
Difference in FiO2 measured during NIV compared to the FiO2 measured during day time with nasal canula at similar O2 flow18 hours

Secondary

MeasureTime frame
Time spent below different O2 levels during NIV despite constant O2 flow and their correlation to day time FiO2 with nasal canula18 hours
levels of O2 adjustment needed to keep FiO2 stable with NIV1 hour

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026