Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00686257
Recruitment Status : Completed
First Posted : May 29, 2008
Results First Posted : August 27, 2012
Last Update Posted : August 27, 2012
Rhode Island Hospital
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
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 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

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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: 1
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

Primary Outcome Measures :
  1. Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most) [ Time Frame: During the first 3 hours of recruitment ]
  2. Time Required for Mask Placement [ Time Frame: at the initiation of NPPV ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Changes in Gas Exchange [ Time Frame: during the first 24 hours of the study ]
  4. Total Length of Time Requiring NPPV [ Time Frame: during hospitalization (after recruitment) ]
  5. Dyspnea [ Time Frame: During the first 3 hours of recruitment ]
  6. Length of Hospital Stay [ Time Frame: during hospitalization (after recruitment) ]
  7. In-hospital Mortality Rate [ Time Frame: during hospitalization (after recruitment) ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
Tufts Medical Center
Rhode Island Hospital
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

Publications of Results:
Responsible Party: Tufts Medical Center Identifier: NCT00686257     History of Changes
Other Study ID Numbers: IRB-6060
First Posted: May 29, 2008    Key Record Dates
Results First Posted: August 27, 2012
Last Update Posted: August 27, 2012
Last Verified: July 2012

Keywords provided by Tufts Medical Center:
acute respiratory insufficiency
noninvasive ventilation
oronasal face mask
total face mask

Additional relevant MeSH terms:
Disease Attributes
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Pulmonary Valve Insufficiency
Pathologic Processes