Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure
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|ClinicalTrials.gov Identifier: NCT00213395|
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : February 16, 2012
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)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2004|
|Study Completion Date :||February 2006|
- Arterial blood gases
- Respiratory frequency
- Severity scores
- Ventilatory settings
- Patient-ventilator adaptation
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 ClinicalTrials.gov identifier (NCT number): NCT00213395
|Pulmonary & Intensive Care Department - Rouen University Hospital,|
|Rouen, France, 76031|
|Principal Investigator:||Antoine CUVELIER, MD, PhD||University Hospital, Rouen|