Official Title: “Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure”

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).

Study Type: Interventional

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

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Device: Total face mask (interface for NPPV)
  • NPPV is applied by this mask, as long as NPPV is received.
• Device: Spectrum oronasal mask (interface for NPPV)
  • NPPV is applied by this mask, as long as NPPV is received.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Patients receiving NPPV by the 'Total Face Mask'
• Active Comparator: 2
  • Patients receiving NPPV by 'standard oronasal mask'

Primary Measures

• mask comfort (as determined by the visual analog scores)
  • Time Frame: During the first 3 hours of recruitment
    Safety Issue?: No

Secondary 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)
    Safety Issue?: No
• changes in vital signs
  • Time Frame: during the first 3 hours of the study
    Safety Issue?: No
• changes in gas exchange
  • Time Frame: during the first 3 hours of the study
    Safety Issue?: No
• total length of time requiring NPPV
  • Time Frame: during hospitalization (after recruitment)
    Safety Issue?: No
• dyspnea
  • Time Frame: during hospitalization (after recruitment)
    Safety Issue?: No
• length of hospital stay
  • Time Frame: during hospitalization (after recruitment)
    Safety Issue?: No
• hospital mortality rate
  • Time Frame: during hospitalization (after recruitment)
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Tufts Medical Center

Overall Clinical Trial Officials and Contacts

Aylin Ozsancak, MD Study Chair Research Fellow  

Overall Contact: Aylin Ozsancak, MD 617-636-3229 aozsancak@tuftsmedicalcenter.org

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00686257

Study ID Number: IRB-6060

ClinicalTrials.gov Identifier: NCT00686257

Health Authority: United States: Institutional Review Board