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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02847416
Other study ID # KKU2016
Secondary ID
Status Completed
Phase N/A
First received July 25, 2016
Last updated March 2, 2018
Start date August 2016
Est. completion date August 28, 2017

Study information

Verified date August 2017
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date August 28, 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- the healthy subjects

- able to breathe against resistive load with the BreatheMAX device

- good conscious and cooperation

Exclusion Criteria:

- fever

Study Design


Related Conditions & MeSH terms


Intervention

Device:
BreatheMAX breathing device


Locations

Country Name City State
Thailand Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University Khon Kaen

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary PSD of oscillatory airway pressure 5 seconds during inspiration and expiration testing period
Secondary mean airway pressure 5 seconds during inspiration and expiration testing period
Secondary oscillatory amplitude 5 seconds during inspiration and expiration testing period
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