A Novel Unidirectional Face Mask During NPPV in COPD Patients

NCT ID: NCT00972868

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-06-30

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).

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COPD

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yandong Jiang

Assistant Professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yandong Jiang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Robert Kacmarek, PhD, RRT

Role: STUDY_CHAIR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2009P000057

Identifier Type: -

Identifier Source: org_study_id