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Completed

NCT Number: NCT02599246

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Home Care Lung Diseases Lung Diseases, Obstructive Oxygen Therapy Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Military teaching hospital Ste Anne

Toulon, VAR, 83000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • informed consent

Exclusion criteria

  • acute on chronic respiratory distress

Treatment and study plan

Primary outcomes

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

    Time frame: 18 hours

Secondary outcomes

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

    Time frame: 18 hours

  2. levels of O2 adjustment needed to keep FiO2 stable with NIV

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

Breas Medical S.A.R.L.

Industry

Registry information

Official study title

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

Acronym: NIVLEAKS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2015
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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