Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure - Full Text View

Sponsored by:	Tufts Medical Center
Information provided by:	Tufts Medical Center
ClinicalTrials.gov Identifier:	NCT00686257

Purpose

The purpose of this study is to compare the Total Face Mask™ (Respironics, Inc., Pittsburgh, PA) (covering whole face) and the standard oronasal facemask (covering nose and mouth) for the emergency treatment of patients with acute respiratory failure with the machine blowing air into the mask placed on the face (noninvasive positive pressure ventilation) (NPPV).

Condition	Intervention	Phase
Acute Respiratory Insufficiency	Device: Total face mask (interface for NPPV) Device: Spectrum oronasal mask (interface for NPPV)	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:

mask comfort (as determined by the visual analog scores) [ Time Frame: During the first 3 hours of recruitment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mask intolerance/ failure rate (as defined by the rate of intubation or the patient's tolerance and/or refusal to proceed with NPPV) [ Time Frame: During hospitalization period (after recruitment into the study) ] [ Designated as safety issue: No ]
changes in vital signs [ Time Frame: during the first 3 hours of the study ] [ Designated as safety issue: No ]
changes in gas exchange [ Time Frame: during the first 3 hours of the study ] [ Designated as safety issue: No ]
total length of time requiring NPPV [ Time Frame: during hospitalization (after recruitment) ] [ Designated as safety issue: No ]
dyspnea [ Time Frame: during hospitalization (after recruitment) ] [ Designated as safety issue: No ]
length of hospital stay [ Time Frame: during hospitalization (after recruitment) ] [ Designated as safety issue: No ]
hospital mortality rate [ Time Frame: during hospitalization (after recruitment) ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2003
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator Patients receiving NPPV by 'standard oronasal mask'	Device: Spectrum oronasal mask (interface for NPPV) NPPV is applied by this mask, as long as NPPV is received.

Detailed Description:

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 Spectrum oronasal mask (also by Respironics, Inc., Pittsburgh, PA) in the acute care setting for patients meeting standard indications for NPPV.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age>18
Either A or B

A. Clinical Criteria: Moderate to severe respiratory distress as evidenced by tachypnea, use of accessory muscles for breathing, or abdominal paradox.

B. Blood Gas and Physiologic Criteria: Gas exchange abnormalities including PaCO2>45 with a pH<7.35, or a PaO2/FiO2 ratio<200.

Exclusion Criteria:

The need for immediate intubation
Medical instability such as hypotensive shock, uncontrolled cardiac ischemia or arrythmias, unstable myocardial infarction, uncontrolled upper gastrointestinal bleeding
Agitation or uncooperativeness, unresponsive to small doses of sedatives
Excretions or inability to protect the airway
Inability to fit the mask
Facial trauma
Upper airway obstruction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686257

Contacts

Contact: Aylin Ozsancak, MD	617-636-3229	aozsancak@tuftsmedicalcenter.org
Contact: Phil Alkana, RRT	617-636-5293	palkana@tuftsmedicalcenter.org

Locations

United States, Massachusetts
Tufts Medical Center	Recruiting
Boston, Massachusetts, United States, 02111
Contact: Aylin Ozsancak, MD 617-636-3229 aozsancak@tuftsmedicalcenter.org
Contact: Phil Alkana, RRT 617-636-5293 palkana@tuftsmedicalcenter.org
Sub-Investigator: Aylin Ozsancak, MD
Sub-Investigator: Phil Alkana, RRT
Principal Investigator: Nicholas S. Hill, MD

Sponsors and Collaborators

Tufts Medical Center

Investigators

Study Chair:	Aylin Ozsancak, MD	Research Fellow
Principal Investigator:	Nicholas S. Hill, MD	Chair of Pulmonary, Critical Care and Sleep Division
Study Director:	Phil Alkana, RRT	Research Fellow

More Information

Responsible Party:	Chair of Pulmonary, Critical Care and Sleep Division ( Nicholas S. Hill, MD )
Study ID Numbers:	IRB-6060
Study First Received:	May 27, 2008
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00686257
Health Authority:	United States: Institutional Review Board

Keywords provided by Tufts Medical Center:

acute respiratory insufficiency
noninvasive ventilation
oronasal face mask
total face mask

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Diseases
Facies
Lung Diseases

Respiration Disorders
Respiratory Distress Syndrome, Adult
Emergencies
Acute respiratory distress syndrome

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009