Status:
WITHDRAWN
A Novel Unidirectional Face Mask During NPPV in COPD Patients
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Acute hypercapnic respiratory failure as a result of an acute exacerbation of COPD defined as PaCO2 \> 50 mmHg, with or without hypoxia, and a respiratory rate of greater than 25/min with the use of accessory muscles of respiration or abdominal paradox;
- Requiring NPPV as assessed by the managing care team.
Exclusion
- Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;
- Patients who have claustrophobia and cannot wear the mask;
- Patients who are hemodynamically unstable;
- Patients who are disoriented and unable to cooperate with the study procedure;
- DNI or DNR status or patients in whom intubation is contraindicated;
- Patients who are currently intubated;
- Patients who recently (\< 6months) had an MI or stroke;
- Pregnant woman; There will be no exclusion based on gender, race or ethnicity.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00972868
Start Date
March 1 2011
End Date
June 1 2013
Last Update
January 16 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114