A Novel Unidirectional Face Mask During Noninvasive Positive Pressure Ventilation (NPPV) in Chronic Obstructive Pulmonary Disease (COPD) Patients - Full Text View

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00972868

Purpose

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).

Condition	Intervention
Chronic Obstructive Pulmonary Disease	Device: A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Use of a Novel Unidirectional Face Mask During Noninvasive Positive Pressure Ventilation (NPPV) in Chronic Obstructive Pulmonary Disease (COPD) Patients

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Reduction in anatomical dead space and improvement in ventilatory efficiency [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	July 2011
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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;
Requiring NPPV as assessed by the managing care team.

Exclusion Criteria:

Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;
Patients who have claustrophobia and cannot wear the mask;
Patients who are hemodynamically unstable;
Patients who are disoriented and unable to cooperate with the study procedure;
DNI or DNR status or patients in whom intubation is contraindicated;
Patients who are currently intubated;
Patients who recently (< 6months) had an MI or stroke;
Pregnant woman; There will be no exclusion based on gender, race or ethnicity.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972868

Contacts

Contact: Robert M Kacmarek, PhD, RRT	617-7244480	rkacmarek@partners.org
Contact: Demet Suleymanci, MD	617-7244480	dsuleymanci@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Not yet recruiting
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:	Yandong Jiang, MD, PhD	Massachusetts General Hospital
Study Chair:	Robert Kacmarek, PhD, RRT	Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Yandong Jiang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00972868 History of Changes
Other Study ID Numbers:	2009P000057
Study First Received:	August 27, 2009
Last Updated:	July 5, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Unidirectional mask
NPPV
COPD
respiratory physiology

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012