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

This study has been terminated.

First Received: September 13, 2005 Last Updated: December 6, 2006 History of Changes

Sponsored by:	University Hospital, Rouen
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00213395

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Study ID Numbers:	04015HP
Study First Received:	September 13, 2005
Last Updated:	December 6, 2006
ClinicalTrials.gov Identifier:	NCT00213395 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Rouen:

Noninvasive ventilation
Acute hypercapnic respiratory failure
Cephalic mask
Facial Mask

Study placed in the following topic categories:

Signs and Symptoms
Respiratory Insufficiency
Respiratory Tract Diseases
Hypercapnia

Facies
Respiration Disorders
Hypoventilation
Signs and Symptoms, Respiratory

Additional relevant MeSH terms:

Signs and Symptoms
Respiratory Insufficiency
Respiratory Tract Diseases
Hypercapnia

Respiration Disorders
Hypoventilation
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on May 07, 2009