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

This study has been completed.
Sponsor:
Collaborator:
Rhode Island Hospital
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00686257
First received: May 27, 2008
Last updated: July 24, 2012
Last verified: July 2012
  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: Comfort full or RT040 oronasal mask (interface for NPPV)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most) [ Time Frame: During the first 3 hours of recruitment ] [ Designated as safety issue: No ]
  • Time Required for Mask Placement [ Time Frame: at the initiation of NPPV ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Early NPPV Discontinuation Rate [ Time Frame: During hospitalization period (after recruitment into the study) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ 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 the first 3 hours of recruitment ] [ Designated as safety issue: No ]
  • Length of Hospital Stay [ Time Frame: during hospitalization (after recruitment) ] [ Designated as safety issue: No ]
  • In-hospital Mortality Rate [ Time Frame: during hospitalization (after recruitment) ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
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
  More Information

Publications:
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00686257     History of Changes
Other Study ID Numbers: IRB-6060
Study First Received: May 27, 2008
Results First Received: May 30, 2012
Last Updated: July 24, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 23, 2014