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

NCT ID: NCT02847416

Last Updated: 2018-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-08-28

Brief Summary

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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

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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

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

BreatheMAX breathing device

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

BreatheMAX breathing device

Intervention Type DEVICE

Interventions

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BreatheMAX breathing device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- fever
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Sujittra Kluayhomthong

Principle Inveatigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sujittra Kluayhomthong, master degree

Role: PRINCIPAL_INVESTIGATOR

faculty of associated medical science, KhonKaen University, Thailand 40002

Locations

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

Khon Kaen, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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KKU2016

Identifier Type: -

Identifier Source: org_study_id

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