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

March 2, 2018 updated by: Sujittra Kluayhomthong, Khon Kaen University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

- fever

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inspiratory group
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
Device: BreatheMAX breathing device
Experimental: expiratory group
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
Device: BreatheMAX breathing device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PSD of oscillatory airway pressure
Time Frame: 5 seconds during inspiration and expiration testing period
5 seconds during inspiration and expiration testing period

Secondary Outcome Measures

Outcome Measure
Time Frame
mean airway pressure
Time Frame: 5 seconds during inspiration and expiration testing period
5 seconds during inspiration and expiration testing period
oscillatory amplitude
Time Frame: 5 seconds during inspiration and expiration testing period
5 seconds during inspiration and expiration testing period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: sujittra Kluayhomthong, master degree, faculty of associated medical science, KhonKaen University, Thailand 40002

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

August 28, 2017

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKU2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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