Back to resultsInvestigation of Efficiency of Breathing With Different Breathing Patterns
Primary Purpose
Respiratory Physiology, Respiratory Insufficiency, Breathing Patterns
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathing Patterns
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Physiology focused on measuring breathing patterns,, unidirectional breathing,, mask ventilation,, respiratory physiology
Eligibility Criteria
Inclusion Criteria:
For healthy subjects:
1. Ten healthy adult (> 18 years of age) volunteers will be recruited from the MGH main campus through intra-hospital e-mail broadcasting. Subjects with the following issues will be excluded from the study.
For patients with respiratory insufficiency:
- Twenty adult (> 18 years of age) patients will be recruited. These patients will be either patients in acute respiratory failure resulting from COPD exacerbation breathing spontaneously only receiving nasal oxygen admitted to the medical floors of the MGH; or patients with diagnosed stable COPD on home oxygen therapy seen by pulmonary physicians in the outpatient clinics or coming to the MGH as study subjects.
Exclusion Criteria:
For healthy volunteers:
- Subjects with facial deformity, heavy beard or moustache which prevents good seal between the mask and the face;
- Subjects who have claustrophobia and cannot wear the mask.
For patients with respiratory insufficiency:
- 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 requiring continuous noninvasive positive pressure ventilation or endotracheal intubation.
Sites / Locations
- Massachusetts General Hospital, Respiratory Care Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Volunteers
Patients
Arm Description
Ten healthy volunteers
Sixteen patients with respiratory insufficiency
Outcomes
Primary Outcome Measures
Determining the anatomic dead space change at variable tidal volumes with four different breathing patterns (nose-in and nose-out, mouth-in and mouth-out, nose-in and mouth-out, mouth-in and nose-out) in healthy volunteers.
Comparing the efficiency of CO2 removal at given minute ventilations with the four different breathing patterns in patients with chronic respiratory failure.
Secondary Outcome Measures
Comparing the efficiency of the study mask which forces subjects to breathe in a manner similar to pursed lip breathing and a regular facemask in healthy volunteers and patients with respiratory failure
Full Information
NCT ID
NCT00784004
First Posted
October 30, 2008
Last Updated
December 1, 2014
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00784004
Brief Title
Investigation of Efficiency of Breathing With Different Breathing Patterns
Official Title
Investigation of Efficiency of Breathing With Different Breathing Patterns in Healthy Volunteers and Patients With Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
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
Our aim in this study is to investigate the efficiency of the breathing with different breathing patterns. Ten volunteers and twenty patients having respiratory problems will be coached on their breathing through specific masks which will provide four different breathing patterns. These patterns will be 1) Breathing in through the nose only and out through the mouth only 2) Breathing in through the mouth only and out through the nose only 3) Breathing in and out through the nose only 4) Breathing in and out through the mouth only The data obtained from volunteers and patients will be compared within and between the groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Physiology, Respiratory Insufficiency, Breathing Patterns
Keywords
breathing patterns,, unidirectional breathing,, mask ventilation,, respiratory physiology
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Volunteers
Arm Type
Other
Arm Description
Ten healthy volunteers
Arm Title
Patients
Arm Type
Other
Arm Description
Sixteen patients with respiratory insufficiency
Intervention Type
Other
Intervention Name(s)
Breathing Patterns
Intervention Description
All subjects will breathe in four different breathing patterns which are provided by specific masks. Patterns are as the following:
Breathing in through the nose only and out through the mouth only
Breathing in through the mouth only and out through the nose only
Breathing in and out through the nose only
Breathing in and out through the mouth only
Primary Outcome Measure Information:
Title
Determining the anatomic dead space change at variable tidal volumes with four different breathing patterns (nose-in and nose-out, mouth-in and mouth-out, nose-in and mouth-out, mouth-in and nose-out) in healthy volunteers.
Time Frame
3 months
Title
Comparing the efficiency of CO2 removal at given minute ventilations with the four different breathing patterns in patients with chronic respiratory failure.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Comparing the efficiency of the study mask which forces subjects to breathe in a manner similar to pursed lip breathing and a regular facemask in healthy volunteers and patients with respiratory failure
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For healthy subjects:
1. Ten healthy adult (> 18 years of age) volunteers will be recruited from the MGH main campus through intra-hospital e-mail broadcasting. Subjects with the following issues will be excluded from the study.
For patients with respiratory insufficiency:
Twenty adult (> 18 years of age) patients will be recruited. These patients will be either patients in acute respiratory failure resulting from COPD exacerbation breathing spontaneously only receiving nasal oxygen admitted to the medical floors of the MGH; or patients with diagnosed stable COPD on home oxygen therapy seen by pulmonary physicians in the outpatient clinics or coming to the MGH as study subjects.
Exclusion Criteria:
For healthy volunteers:
Subjects with facial deformity, heavy beard or moustache which prevents good seal between the mask and the face;
Subjects who have claustrophobia and cannot wear the mask.
For patients with respiratory insufficiency:
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 requiring continuous noninvasive positive pressure ventilation or endotracheal intubation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yandong Jiang, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital, Respiratory Care Laboratory
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24782549
Citation
Sulemanji DS, Bao F, Jiang Y, Kacmarek RM. A unidirectional breathing pattern improves breathing efficiency in subjects with severe COPD. Respir Care. 2014 Oct;59(10):1487-93. doi: 10.4187/respcare.02899. Epub 2014 Apr 29.
Results Reference
derived
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Investigation of Efficiency of Breathing With Different Breathing Patterns
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