NCT00686257|CompletedResults
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Sponsor study identifier
interventional
60
1 country
2
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
May 27, 2008
Actual (reported)May 29, 2008
Actual (reported)June 2008
Actual (reported)June 2008
Actual (reported)August 27, 2012
Actual (reported)Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)
During the first 3 hours of recruitment
Time Required for Mask Placement
at the initiation of NPPV
Early NIV Discontinuation Rate
During hospitalization period (after recruitment into the study)
Deterioration Vital Signs
during the first 24 hours of the study
Deterioration in Gas Exchange
during the first 24 hours of the study
Total Length of Time Requiring NIV
during hospitalization (after recruitment)
Length of Hospital Stay
during hospitalization (after recruitment)
Patients receiving NPPV by the 'Total Face Mask'
Patients receiving NPPV by 'standard oronasal mask'
NPPV is applied by this mask, as long as NPPV is received.
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.
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Ozsancak A, Sidhom SS, Liesching TN, Howard W, Hill NS. Evaluation of the total face mask for noninvasive ventilation to treat acute respiratory failure. Chest. 2011 May;139(5):1034-1041. doi: 10.1378/chest.10-1905. Epub 2011 Feb 17.
Could not blind subjects or investigators
Aylin Ozsancak, MD
Research Fellow
Nicholas S. Hill, MD
Chair of Pulmonary, Critical Care and Sleep Division
Samy Sidhom, MD, MPH
Clinical Fellow
60 participants (actual enrollment reported by the registry).
First Submitted
May 27, 2008
First Posted
May 29, 2008
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Wales
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)Last Updated
June 25, 2018
Results First Posted
August 27, 2012
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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