CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Total face mask (interface for NPPV) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00686257
NCT00686257N/ACompleted
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Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure

Tufts Medical Center·interventional·Posted May 29, 2008·Updated Jun 25, 2018

In Brief

A clinical study evaluating Total face mask (interface for NPPV) and Comfort full or RT040 oronasal mask (interface for NPPV) for Acute Respiratory Insufficiency. Completed, enrolled 60 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Respiratory Insufficiency
CountriesUnited States
CollaboratorsRhode Island Hospital

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 29, 2008
Enrollment StartJan 1, 2003
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 18.1 years ago

Interventions

Total face mask (interface for NPPV)device

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

Comfort full or RT040 oronasal mask (interface for NPPV)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.