Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00972868
First received: August 27, 2009
Last updated: November 5, 2012
Last verified: November 2012
  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:


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: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 S Sulemanji, MD 617-7244480 dsulemanji@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, Assistant Professor of Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00972868     History of Changes
Other Study ID Numbers: 2009P000057
Study First Received: August 27, 2009
Last Updated: November 5, 2012
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014