Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Unidirectional mask, NPPV, COPD, respiratory physiology
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 and out through the nose) in COPD patients with breathing difficulties requiring noninvasive positive pressure ventilation (NPPV).
Interventions
DEVICEA unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)
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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in anatomical dead space and improvement in ventilatory efficiency | 30 minutes |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed