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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00213395
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : February 16, 2012
Information provided by:
University Hospital, Rouen

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.

Condition or disease Intervention/treatment Phase
Acute Hypercapnic Respiratory Failure Device: Interface for noninvasive ventilation Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2004
Study Completion Date : February 2006

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Primary Outcome Measures :
  1. Arterial blood gases

Secondary Outcome Measures :
  1. Respiratory frequency
  2. Severity scores
  3. Ventilatory settings
  4. Patient-ventilator adaptation
  5. Tolerance
  6. Outcome
  7. Complications

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00213395

Pulmonary & Intensive Care Department - Rouen University Hospital,
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Antoine CUVELIER, MD, PhD University Hospital, Rouen Identifier: NCT00213395     History of Changes
Other Study ID Numbers: 2004/015/HP
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: February 16, 2012
Last Verified: February 2012

Keywords provided by University Hospital, Rouen:
Noninvasive ventilation
Acute hypercapnic respiratory failure
Cephalic mask
Facial Mask

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms