Back to resultsA Study of Pressure and Flow Characteristics During Inspiration and Expiration Using BreatheMAX® in Healthy Subjects (PFBM)
Primary Purpose
Healthy Subjects
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
BreatheMAX breathing device
Sponsored by
About this trial
This is an interventional other trial for Healthy Subjects
Eligibility Criteria
Inclusion Criteria:
- the healthy subjects
- able to breathe against resistive load with the BreatheMAX device
- good conscious and cooperation
Exclusion Criteria:
- fever
Sites / Locations
- Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Inspiratory group
expiratory group
Arm Description
the subjects will be instructed to inspire as deeply as possible with steady flow rate for 3 seconds with end-inspiratory pause for 2-3 seconds through the inspiratory circuit and follow by passive exhalation
the subjects will be instructed to inspire as deeply as possible through the nose with end-inspiratory pause for 2-3 seconds and partially forced exhalation with reach to 1/3 of expiratory reserve volume (ERV) for at least 3 seconds through expiratory circuit
Outcomes
Primary Outcome Measures
PSD of oscillatory airway pressure
Secondary Outcome Measures
mean airway pressure
oscillatory amplitude
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02847416
Brief Title
A Study of Pressure and Flow Characteristics During Inspiration and Expiration Using BreatheMAX® in Healthy Subjects
Acronym
PFBM
Official Title
to Explore the Characteristics of Mean Airway Pressure, Oscillatory Amplitude and Power Spectral Density (PSD) of Oscillatory Airway Pressure That Generate by Various Loaded and Flow Rate During Expiration and Inspiration in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
the aim of this study are to explore the characteristics of mean airway pressure, oscillatory amplitude and power spectral density (PSD) of oscillatory airway pressure that generate by various loaded and flow rate during expiration and inspiration in healthy subjects and to explore the best loaded and flow rate for airway secretion clearance using the BreatheMAX® device
Detailed Description
For inspiratory group, the resistive load 3, 4, 5, 6 and 7 cm H2O were test with three flow rate: 0.2, 0.4, and 0.6 L/sec in each load. In each flow rate, the subjects were instructed to inspire as deeply as possible with steady flow rate for 3 seconds with end-inspiratory pause for 2-3 seconds through the inspiratory circuit and follow by passive exhalation. For expiratory group, the resistive load and flow rate were test similar inspiratory group. In each flow rate, the subjects were instructed to inspire as deeply as possible through the nose with end-inspiratory pause for 2-3 seconds and partially forced exhalation with reach to 1/3 of expiratory reserve volume (ERV) for at least 3 seconds through expiratory circuit
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory group
Arm Type
Experimental
Arm Description
the subjects will be instructed to inspire as deeply as possible with steady flow rate for 3 seconds with end-inspiratory pause for 2-3 seconds through the inspiratory circuit and follow by passive exhalation
Arm Title
expiratory group
Arm Type
Experimental
Arm Description
the subjects will be instructed to inspire as deeply as possible through the nose with end-inspiratory pause for 2-3 seconds and partially forced exhalation with reach to 1/3 of expiratory reserve volume (ERV) for at least 3 seconds through expiratory circuit
Intervention Type
Device
Intervention Name(s)
BreatheMAX breathing device
Primary Outcome Measure Information:
Title
PSD of oscillatory airway pressure
Time Frame
5 seconds during inspiration and expiration testing period
Secondary Outcome Measure Information:
Title
mean airway pressure
Time Frame
5 seconds during inspiration and expiration testing period
Title
oscillatory amplitude
Time Frame
5 seconds during inspiration and expiration testing period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
the healthy subjects
able to breathe against resistive load with the BreatheMAX device
good conscious and cooperation
Exclusion Criteria:
- fever
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sujittra Kluayhomthong, master degree
Organizational Affiliation
faculty of associated medical science, KhonKaen University, Thailand 40002
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study of Pressure and Flow Characteristics During Inspiration and Expiration Using BreatheMAX® in Healthy Subjects
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