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Completed

NCT Number: NCT02847416

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

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

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Key information

Conditions

Healthy Subjects

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University

Khon Kaen, 40002, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the healthy subjects
  • able to breathe against resistive load with the BreatheMAX device
  • good conscious and cooperation

Exclusion criteria

  • fever

Treatment and study plan

BreatheMAX breathing device

Device

Primary outcomes

  1. PSD of oscillatory airway pressure

    Time frame: 5 seconds during inspiration and expiration testing period

Secondary outcomes

  1. mean airway pressure

    Time frame: 5 seconds during inspiration and expiration testing period

  2. oscillatory amplitude

    Time frame: 5 seconds during inspiration and expiration testing period

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study 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

Acronym: PFBM

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2016
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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