Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 96 of 79879 for:    subjects

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02847416
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sujittra Kluayhomthong, Khon Kaen University

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Subjects Device: BreatheMAX breathing device Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Other
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
Study Start Date : August 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : August 28, 2017

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



Primary Outcome Measures :
  1. PSD of oscillatory airway pressure [ Time Frame: 5 seconds during inspiration and expiration testing period ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- fever


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847416


Locations
Layout table for location information
Thailand
Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Layout table for investigator information
Principal Investigator: sujittra Kluayhomthong, master degree faculty of associated medical science, KhonKaen University, Thailand 40002

Layout table for additonal information
Responsible Party: Sujittra Kluayhomthong, Principle Inveatigator, Khon Kaen University
ClinicalTrials.gov Identifier: NCT02847416     History of Changes
Other Study ID Numbers: KKU2016
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes