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

Completed · Not applicable

Conditions studied: Acute Respiratory Insufficiency

In brief

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).

Key facts

Study ID

NCT00686257

Run by

Tufts Medical Center

People needed

60

Starts

2003-01-01

Expected to finish

2008-06-01

Last updated by the study team

2018-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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