Back to resultsA Novel Unidirectional Face Mask During NPPV in COPD Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Unidirectional mask, NPPV, COPD, respiratory physiology
Eligibility 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COPD
Arm Description
Thirty adult (> 18 years of age) patients in acute hypercapnic respiratory failure resulting from COPD and requiring Noninvasive Positive Pressure Ventilation (NPPV)
Outcomes
Primary Outcome Measures
Reduction in anatomical dead space and improvement in ventilatory efficiency
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.
Full Information
NCT ID
NCT00972868
First Posted
August 27, 2009
Last Updated
January 13, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00972868
Brief Title
A Novel Unidirectional Face Mask During NPPV in COPD Patients
Official Title
Use of a Novel Unidirectional Face Mask During Noninvasive Positive Pressure Ventilation (NPPV) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Inability to enrole subjucts.
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Unidirectional mask, NPPV, COPD, respiratory physiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD
Arm Type
Experimental
Arm Description
Thirty adult (> 18 years of age) patients in acute hypercapnic respiratory failure resulting from COPD and requiring Noninvasive Positive Pressure Ventilation (NPPV)
Intervention Type
Device
Intervention Name(s)
A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)
Intervention Description
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 Measure Information:
Title
Reduction in anatomical dead space and improvement in ventilatory efficiency
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yandong Jiang, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Kacmarek, PhD, RRT
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
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A Novel Unidirectional Face Mask During NPPV in COPD Patients
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