CClinicalTrials.gg
Status unknownNCT01090804ESMOSCUpdated Mar 23, 2010

The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance

A Phase 2/3 interventional study of BreatheMAX breathing device in Lung Disease, sponsored by Khon Kaen University. Status unknown at 1 site in Thailand. Open to participants aged 15 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-03-23.

Sponsored by Khon Kaen University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
15 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to determined effects of BreatheMAX on secretion clearance.

02

Conditions studied

  • Lung Disease

Browse trials for

Keywords

  • BreatheMAX breathing device
  • Secretion clearance
  • Ventilatory dependence
  • Intubated patients
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 14 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 160 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • One sign of secretion accumulation in bronchi
  • Stable cardiopulmonary function
  • Good consciousness and good co-operation

Exclusion criteria

Exclusion Criteria:

  • Massive hemoptysis
  • Pneumothorax (untreated)
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    breathing exercise

    BreatheMAX breathing device is Water pressure Threshold Bottle. The level of water in the cylinder determines the load for treatment. In the treatment using 20% PNIP (Peak negative inspiratory pressure) was performed with 6-10 breaths/set; 10 set/day

    Device: BreatheMAX breathing device

Interventions

  • DeviceBreatheMAX breathing device

    secretion clearance, breathing exercise

06

What researchers measure

Primary outcomes

  1. secretion wet weight (gram)

    Airway mucus secretion was collected for three hours before and ten hours after treatment based on an auditory airway secretion sound and collected again at 02.00-07.00 am.The mucus secretion was collected by sterile suctioning technique via tracheostomy tube without adding any saline or sterile water.

    Time frame: Three hours before, ten hours after treatment and night-time (02.00-07.00 am.)

  2. viscosity of secretion

    The secretion were collected in three hours before and after treatment, It were measured viscosity by First The mucus was gently homogenized by tissue grinder 5 ml (Cw11-205, Cowie, UK) for six minute at 37 degree celsius Second using Micro-Oswald viscometers with a capillary diameter of 0.77 mm for viscosity measure at same temperature in each sample(before and after).

    Time frame: Three hours before and after treatment

Secondary outcomes

  1. Heart rate (beat/min)

    Heart rate was monitored before, during and immediate after breathing exercise with BreatheMAX (6-10 beats/set, 10 set/day and rest between ste for 1 minute)

    Time frame: Before, during breathing exercise with device and immediate after treatment

  2. Oxygen saturation (%SpO2)

    Oxygen saturation was monitored before, during and immediate after breathing exercise with BreatheMAX (6-10 beats/set, 10 set/day and rest between set for 1 minute)

    Time frame: Before, during breathing exercise with device and immediate after treatment

  3. Respiratory rate (times/min)

    Respiratory rate was measured by manual for 1 minute before, rest interval between set and immediate after breathing exercise with device (during the patients reconnection mechanical ventilation)

    Time frame: In rest interval between set (1 minute)

07

Study locations

1 of 1 sites recruiting
  • Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University
    Muang, Khon Kaen 40002, Thailand
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01090804
Lead sponsor
Khon Kaen University
First posted
Mar 23, 2010
Start date
Aug 2009
Primary completion
Dec 2009
Last update
Mar 23, 2010

Study contacts

Miss Sujittra Kluayhomthong, Bachelor
Contact
rabbit_tigger@hotmail.com
081-379-0647
Mrs. Chulee Jones, Philosophy
Contact
Chujones46@yahoo.co.uk
664-320-2399
Sujittra Kluayhomthong, Bachelor
study chair · Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
Chulee CU Jones, Philosophy
study director · Physical Therapy Department, Faculty of Associated Medical Sciences, Khon Kaen university, Thailand
Wilaiwan Khrisanapant, Philosophy
study director · Department of physiology, Faculty of medicine, Khon Kaen university

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion