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Clinical Trials/NCT00213395
NCT00213395
Terminated
N/A

Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure

University Hospital, Rouen1 site in 1 countryOctober 2004

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Hypercapnic Respiratory Failure
Sponsor
University Hospital, Rouen
Locations
1
Primary Endpoint
Arterial blood gases
Status
Terminated
Last Updated
14 years ago

Overview

Brief Summary

Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are determinant to get an optimal NIV efficacy in parallel with ventilatory comfort.

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.

Registry
clinicaltrials.gov
Start Date
October 2004
End Date
February 2006
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Rouen

Eligibility Criteria

Inclusion Criteria

  • Acute hypercapnic respiratory failure
  • Indication to noninvasive ventilation

Exclusion Criteria

  • Requirement for endotracheal intubation
  • Proven pulmonary embolism
  • Present or previous history of ophthalmologic disease

Outcomes

Primary Outcomes

Arterial blood gases

Secondary Outcomes

  • Respiratory frequency
  • Severity scores
  • Ventilatory settings
  • Patient-ventilator adaptation
  • Tolerance
  • Outcome
  • Complications

Study Sites (1)

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