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

NCT ID: NCT00686257

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2008-06-30

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).

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.

Conditions

Acute Respiratory Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Patients receiving NPPV by the 'Total Face Mask'

Group Type: EXPERIMENTAL

Total face mask (interface for NPPV)

Intervention Type: DEVICE

NPPV is applied by this mask, as long as NPPV is received.

2

Patients receiving NPPV by 'standard oronasal mask'

Group Type: ACTIVE_COMPARATOR

Comfort full or RT040 oronasal mask (interface for NPPV)

Intervention Type: DEVICE

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.

Interventions

Total face mask (interface for NPPV)

NPPV is applied by this mask, as long as NPPV is received.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

cephalic mask; Full face mask

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aylin Ozsancak, MD

Role: STUDY_CHAIR

Research Fellow

Nicholas S. Hill, MD

Role: PRINCIPAL_INVESTIGATOR

Chair of Pulmonary, Critical Care and Sleep Division

Samy Sidhom, MD, MPH

Role: STUDY_DIRECTOR

Clinical Fellow

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21330385 (View on PubMed)

Other Identifiers

IRB-6060

Identifier Type: -

Identifier Source: org_study_id