A Novel Unidirectional Face Mask During Noninvasive Positive Pressure Ventilation (NPPV) in Chronic Obstructive Pulmonary Disease (COPD) Patients



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:March 2013
End Date:March 2015
Contact:Robert M Kacmarek, PhD, RRT
Email:rkacmarek@partners.org
Phone:617-7244480

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Use of a Novel Unidirectional Face Mask During Noninvasive Positive Pressure Ventilation (NPPV) in Chronic Obstructive Pulmonary Disease (COPD) Patients

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).


Inclusion Criteria:

1. 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;

2. Requiring NPPV as assessed by the managing care team.

Exclusion Criteria:

1. Patients with facial deformity, heavy beard or moustache which prevents a good seal
between the mask and the face;

2. Patients who have claustrophobia and cannot wear the mask;

3. Patients who are hemodynamically unstable;

4. Patients who are disoriented and unable to cooperate with the study procedure;

5. DNI or DNR status or patients in whom intubation is contraindicated;

6. Patients who are currently intubated;

7. Patients who recently (< 6months) had an MI or stroke;

8. Pregnant woman; There will be no exclusion based on gender, race or ethnicity.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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