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

NCT ID: NCT02599246

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-17

Study Completion Date

2016-02-24

Brief Summary

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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

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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.

Conditions

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COPD Home Care Oxygen Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* informed consent

Exclusion Criteria

* acute on chronic respiratory distress
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Breas Medical S.A.R.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe GOUTORBE, MD

Role: PRINCIPAL_INVESTIGATOR

Military teaching hospital Ste ANNE

Locations

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Military teaching hospital Ste Anne

Toulon, VAR, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32694183 (View on PubMed)

Other Identifiers

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NIVLEAKS1

Identifier Type: -

Identifier Source: org_study_id

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