A Novel Unidirectional Face Mask During NPPV in COPD Patients

Massachusetts General Hospital

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Reduction in anatomical dead space and improvement in ventilatory efficiency

Time frame: 30 minutes

Secondary Outcomes

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.

Time frame: 30 minutes

Data from ClinicalTrials.gov

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