Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure
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|ClinicalTrials.gov Identifier: NCT00686257|
Recruitment Status : Completed
First Posted : May 29, 2008
Results First Posted : August 27, 2012
Last Update Posted : August 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Insufficiency||Device: Total face mask (interface for NPPV) Device: Comfort full or RT040 oronasal mask (interface for NPPV)||Phase 4|
Despite its demonstrated efficacy in treating selected patients with acute respiratory failure, the application of NPPV is still plagued by a substantial failure rate, ranging from below 10% to above 40%. Mask intolerance ranks as one of the most common causes of failure. This is related to ill-fitting masks, mask discomfort (despite a properly fitted mask), excessively tightened straps, excessive air leaks around the mask or through the mouth, and claustrophobia.
The most commonly used masks in the acute care setting are either oronasal masks that cover the nose and mouth, or nasal masks that cover the nose alone. Both mask types usually consist of clear plastic dome-shaped mask with a soft silicon gasket to create an air seal with the skin. While this approach is usually successful, it may lead to patient discomfort and/or an air leak secondary to the difficulty in creating an effective seal over the bridge of the nose and over mobile structures such as the mandible. The Total Face Mask ™ (Respironics, Inc., Pittsburgh, PA) uses a different approach to avoid some of these limitations. Considerably larger than a standard oronasal mask, it covers the entire face and creates an air seal using a silicon gasket around the parameter of the face. In this way, gasket pressure is more evenly distributed, and discomfort over the bridge of the nose or chin is eliminated, and air leaking reduced. In addition, because one mask size fits virtually all patients, the Total Face Mask ™ facilitates the fitting process and permits more rapid initiation of ventilatory assistance. Clinical experience to date suggests that claustrophobia is not a common problem with the Total Face Mask ™ despite its size, and that its contribution to dead space is comparable to that of most oronasal masks.
The following protocol aims to compare use of the Total Face Mask ™ to the Comfort Full oronasal mask (also by Respironics, Inc., Pittsburgh, PA)or RT040 oronasal mask (Fisher&Paykel Inc., Wellington, NZ) in the acute care setting for patients meeting standard indications for NPPV.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Patients receiving NPPV by the 'Total Face Mask'
Device: Total face mask (interface for NPPV)
NPPV is applied by this mask, as long as NPPV is received.
Other Name: cephalic mask
Active Comparator: 2
Patients receiving NPPV by 'standard oronasal mask'
Device: Comfort full or RT040 oronasal mask (interface for NPPV)
NPPV is applied by one of these masks (Comfort full or RT040 masks used at Rhode Island Hospital and Tufts Medical Center respectively), as long as NPPV is received.
Other Name: Full face mask
- Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most) [ Time Frame: During the first 3 hours of recruitment ]
- Time Required for Mask Placement [ Time Frame: at the initiation of NPPV ]
- Early NPPV Discontinuation Rate [ Time Frame: During hospitalization period (after recruitment into the study) ]defined as the inability of the patient to be maintained on NPPV using the assigned mask while there was still an indication for ventilatory support
- Changes in Vital Signs [ Time Frame: during the first 24 hours of the study ]At initiation;30 minutes, 1 hour, 3 hours and 24 hours after NPPV initiation
- Changes in Gas Exchange [ Time Frame: during the first 24 hours of the study ]
- Total Length of Time Requiring NPPV [ Time Frame: during hospitalization (after recruitment) ]
- Dyspnea [ Time Frame: During the first 3 hours of recruitment ]
- Length of Hospital Stay [ Time Frame: during hospitalization (after recruitment) ]
- In-hospital Mortality Rate [ Time Frame: during hospitalization (after recruitment) ]
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): NCT00686257
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Study Chair:||Aylin Ozsancak, MD||Research Fellow|
|Principal Investigator:||Nicholas S. Hill, MD||Chair of Pulmonary, Critical Care and Sleep Division|
|Study Director:||Samy Sidhom, MD, MPH||Clinical Fellow|