Status:
COMPLETED
Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Rhode Island Hospital
Conditions:
Acute Respiratory Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
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 tr...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00686257
Start Date
January 1 2003
End Date
June 1 2008
Last Update
June 25 2018
Active Locations (2)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
2
Rhode Island Hospital
Providence, Rhode Island, United States, 02903