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

This study has been terminated.
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213395
First received: September 13, 2005
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Acute Hypercapnic Respiratory Failure
 Device: Interface for noninvasive ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Arterial blood gases

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

Study Start Date: October 2004
Estimated Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213395

Locations
France
Pulmonary & Intensive Care Department - Rouen University Hospital,
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Antoine CUVELIER, MD, PhD University Hospital, Rouen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00213395     History of Changes
Other Study ID Numbers: 2004/015/HP
Study First Received: September 13, 2005
Last Updated: February 14, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 16, 2013