A Study of Pressure and Flow Characteristics During Inspiration and Expiration Using BreatheMAX® in Healthy Subjects

Healthy Subjects Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847416
• Other study ID #: KKU2016
• 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
• 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

Related Conditions & MeSH terms

• Healthy Subjects
• Respiratory Aspiration

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