Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure
NCT ID: NCT00213395
Last Updated: 2012-02-16
Study Results
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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TERMINATED
NA
INTERVENTIONAL
2004-10-31
2006-02-28
Brief Summary
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Facial masks during NIV are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. In order to limit these side effects, a cephalic interface has been recently designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. However, this mask has a high volume that may interfere with NIV efficacy and may also induce claustrophobic sensations.
The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during AHRF.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Interface for noninvasive ventilation
Eligibility Criteria
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Inclusion Criteria
* Indication to noninvasive ventilation
Exclusion Criteria
* Proven pulmonary embolism
* Present or previous history of ophthalmologic disease
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Principal Investigators
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Antoine CUVELIER, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Pulmonary & Intensive Care Department - Rouen University Hospital,
Rouen, , France
Countries
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Other Identifiers
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2004/015/HP
Identifier Type: -
Identifier Source: org_study_id
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