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 Overview

• Status: Completed
• Conditions: Acute Respiratory Insufficiency
• Intervention / Treatment: Device: Total face mask (interface for NPPV); Device: Comfort full or RT040 oronasal mask (interface for NPPV)

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Full face mask

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early NIV Discontinuation Rate	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	During hospitalization period (after recruitment into the study)
Deterioration Vital Signs		during the first 24 hours of the study
Deterioration in Gas Exchange		during the first 24 hours of the study
Total Length of Time Requiring NIV		during hospitalization (after recruitment)
Length of Hospital Stay		during hospitalization (after recruitment)
In-hospital Mortality Rate		during hospitalization (after recruitment)

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: Rhode Island Hospital
• Investigators: 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 and helpful links

General Publications

• Ozsancak A, Sidhom SS, Liesching TN, Howard W, Hill NS. Evaluation of the total face mask for noninvasive ventilation to treat acute respiratory failure. Chest. 2011 May;139(5):1034-1041. doi: 10.1378/chest.10-1905. Epub 2011 Feb 17.

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: May 27, 2008
• First Submitted That Met QC Criteria: May 28, 2008
• First Posted (Estimate): May 29, 2008

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: noninvasive ventilation; acute respiratory insufficiency; oronasal face mask; total face mask
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Emergencies; Respiratory Insufficiency
• Other Study ID Numbers: IRB-6060