A Novel Unidirectional Face Mask During NPPV in COPD Patients

Not Applicable

Withdrawn

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)

• Registration Number: NCT00972868
• Lead Sponsor: Massachusetts General Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Study Start: 2011-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COPD	A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)	Thirty adult (\> 18 years of age) patients in acute hypercapnic respiratory failure resulting from COPD and requiring Noninvasive Positive Pressure Ventilation (NPPV)

Primary Outcome Measures

Name	Time	Method
Reduction in anatomical dead space and improvement in ventilatory efficiency	30 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States