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A Novel Unidirectional Face Mask During NPPV in COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00972868
Recruitment Status : Withdrawn (Inability to enrole subjucts.)
First Posted : September 9, 2009
Last Update Posted : January 16, 2017
Information provided by (Responsible Party):
Yandong Jiang, 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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

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.

Primary Outcome Measures :
  1. Reduction in anatomical dead space and improvement in ventilatory efficiency [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00972868

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Yandong Jiang, MD, PhD Massachusetts General Hospital
Study Chair: Robert Kacmarek, PhD, RRT Massachusetts General Hospital
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Responsible Party: Yandong Jiang, Assistant Professor of Anesthesia, Massachusetts General Hospital Identifier: NCT00972868    
Other Study ID Numbers: 2009P000057
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Keywords provided by Yandong Jiang, Massachusetts General Hospital:
Unidirectional mask
respiratory physiology
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases