N/A
Completed N=60
Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure
Acute Respiratory Insufficiency
Source: ClinicalTrials.gov NCT00686257 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most) — 3.2; 3.3 units on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most) |
3.2; 3.3 | — |
| PRIMARY Time Required for Mask Placement |
5; 3.5 | — |
| SECONDARY Early NIV Discontinuation Rate |
12; 16 | — |
| SECONDARY Deterioration Vital Signs |
7; 3 | — |
| SECONDARY Deterioration in Gas Exchange |
3; 3 | — |
| SECONDARY Total Length of Time Requiring NIV |
15.7; 6.05 | — |
| SECONDARY Length of Hospital Stay |
19.2; 10.9 | — |
| SECONDARY In-hospital Mortality Rate |
6; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT00686257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.