Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance (ESMOSC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Khon Kaen University.
Recruitment status was  Recruiting
Information provided by:
Khon Kaen University Identifier:
First received: January 7, 2010
Last updated: March 22, 2010
Last verified: January 2010
The purpose of this study is to determined effects of BreatheMAX on secretion clearance.

Condition Intervention Phase
Lung Disease
Device: BreatheMAX breathing device
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Effectiveness of BreatheMAX Breathing Device on Airway Secretion Clearance in Patients With Ventilatory Dependence

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • secretion wet weight (gram) [ Time Frame: Three hours before, ten hours after treatment and night-time (02.00-07.00 am.) ] [ Designated as safety issue: No ]
    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.

  • viscosity of secretion [ Time Frame: Three hours before and after treatment ] [ Designated as safety issue: No ]
    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).

Secondary Outcome Measures:
  • Heart rate (beat/min) [ Time Frame: Before, during breathing exercise with device and immediate after treatment ] [ Designated as safety issue: Yes ]
    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)

  • Oxygen saturation (%SpO2) [ Time Frame: Before, during breathing exercise with device and immediate after treatment ] [ Designated as safety issue: Yes ]
    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)

  • Respiratory rate (times/min) [ Time Frame: In rest interval between set (1 minute) ] [ Designated as safety issue: Yes ]
    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)

Estimated Enrollment: 14
Study Start Date: August 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
secretion clearance, breathing exercise


Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Massive hemoptysis
  • Pneumothorax (untreated)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01090804

Contact: Miss Sujittra Kluayhomthong, Bachelor 081-379-0647
Contact: Mrs. Chulee Jones, Philosophy 664-320-2399

Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University Recruiting
Muang, Khon Kaen, Thailand, 40002
Contact: Sujittra Kluayhomthong, Bachelor    668-139-0647   
Contact: Chulee CU Jones, Philosophy    664-320-2399   
Sponsors and Collaborators
Khon Kaen University
Study Chair: Sujittra Kluayhomthong, Bachelor Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
Study Director: Chulee CU Jones, Philosophy Physical Therapy Department, Faculty of Associated Medical Sciences, Khon Kaen university, Thailand
Study Director: Wilaiwan Khrisanapant, Philosophy Department of physiology, Faculty of medicine, Khon Kaen university
  More Information

Responsible Party: Khon Kaen university ( Graduate School ), Khon Kaen University Identifier: NCT01090804     History of Changes
Other Study ID Numbers: 47660279 
Study First Received: January 7, 2010
Last Updated: March 22, 2010
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
BreatheMAX breathing device
Secretion clearance
Ventilatory dependence
Intubated patients

Additional relevant MeSH terms:
Lung Diseases
Respiratory Aspiration
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes processed this record on October 27, 2016