A Novel Unidirectional Face Mask During NPPV in COPD Patients

Withdrawn before enrolling · Not applicable

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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).

Key facts

Study ID

NCT00972868

Run by

Massachusetts General Hospital

People needed

0

Starts

2011-03-01

Expected to finish

2013-06-01

Last updated by the study team

2017-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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