A Novel Unidirectional Face Mask During NPPV in COPD Patients

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).

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: A 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in anatomical dead space and improvement in ventilatory efficiency	30 minutes

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Study Chair: Robert Kacmarek, PhD, RRT, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: September 8, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): January 16, 2017
• Last Update Submitted That Met QC Criteria: January 13, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: COPD; NPPV; respiratory physiology; Unidirectional mask
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2009P000057