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

This study has been terminated.
Information provided by:
University Hospital, Rouen Identifier:
First received: September 13, 2005
Last updated: February 14, 2012
Last verified: February 2012

September 13, 2005
February 14, 2012
October 2004
Not Provided
Arterial blood gases
Same as current
Complete list of historical versions of study NCT00213395 on Archive Site
  • Respiratory frequency
  • Severity scores
  • Ventilatory settings
  • Patient-ventilator adaptation
  • Tolerance
  • Outcome
  • Complications
Same as current
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Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure
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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.

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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Hypercapnic Respiratory Failure
Device: Interface for noninvasive ventilation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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February 2006
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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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
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University Hospital, Rouen
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Principal Investigator: Antoine CUVELIER, MD, PhD University Hospital, Rouen
University Hospital, Rouen
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP