A Novel Unidirectional Face Mask During NPPV in COPD Patients

Mass General Brigham

Status: Withdrawn

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)

Study type: Interventional

Funder types: Other

Identifiers

NCT00972868

2009P000057

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

COPD

Experimental group

Description:

Thirty adult (\> 18 years of age) patients in acute hypercapnic respiratory failure resulting from COPD and requiring Noninvasive Positive Pressure Ventilation (NPPV)

Treatment:

Device: A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)