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

NCT00686257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-06-25

Study results available
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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).

Conditions

  • Acute Respiratory Insufficiency

Interventions

DEVICE

Total face mask (interface for NPPV)

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

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.

Sponsors & Collaborators

  • Rhode Island Hospital

    collaborator OTHER

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Aylin Ozsancak, MD · Research Fellow

  • Nicholas S. Hill, MD · Chair of Pulmonary, Critical Care and Sleep Division

  • Samy Sidhom, MD, MPH · Clinical Fellow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00686257 on ClinicalTrials.gov