Sponsor study identifier
interventional
0
1 country
1
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to determine the feasibility, safety and efficacy of a unidirectional breathing mask (breathe in through the nose and out through the mouth or breathe in through the mouth and out through the nose) in COPD patients with breathing difficulties requiring noninvasive positive pressure ventilation (NPPV).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
August 27, 2009
Actual (reported)September 9, 2009
Actual (reported)March 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Reduction in anatomical dead space and improvement in ventilatory efficiency
30 minutes
Improvement of ventilation rate, tidal volume, end tidal CO2, arterial pH, PaCO2, and PaO2, SpO2, pulse rate, blood pressure and patient rating of comfort of each ventilatory pattern.
30 minutes
Thirty adult (\> 18 years of age) patients in acute hypercapnic respiratory failure resulting from COPD and requiring Noninvasive Positive Pressure Ventilation (NPPV)
The regular face mask will be replaced with the study mask and patients will receive NPPV via the study mask for 30 min. The study mask insures a unidirectional breathing pattern, in through the nose and out through the mouth or in through the mouth and out through the nose. The sequence of these two breathing patterns with opposite flow direction will be chosen randomly. Each will be applied for 30 min with data collected during and at the end of the period.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Yandong Jiang, MD, PhD
Massachusetts General Hospital
Robert Kacmarek, PhD, RRT
Massachusetts General Hospital
0 participants (actual enrollment reported by the registry).
First Submitted
August 27, 2009
First Posted
September 9, 2009
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)
Contact the study team to confirm eligibility.
Primary Completion
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 16, 2017
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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