Back to resultsThe Effectiveness of BreatheMAX Breathing Device on Secretion Clearance (ESMOSC)
Primary Purpose
Lung Disease
Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
BreatheMAX breathing device
Sponsored by
About this trial
This is an interventional treatment trial for Lung Disease focused on measuring BreatheMAX breathing device, Secretion clearance, Ventilatory dependence, Intubated patients
Eligibility Criteria
Inclusion Criteria:
- One sign of secretion accumulation in bronchi
- Stable cardiopulmonary function
- Good consciousness and good co-operation
Exclusion Criteria:
- Massive hemoptysis
- Pneumothorax (untreated)
Sites / Locations
- Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
breathing exercise
Arm Description
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
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01090804
Brief Title
The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance
Acronym
ESMOSC
Official Title
The Effectiveness of BreatheMAX Breathing Device on Airway Secretion Clearance in Patients With Ventilatory Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Khon Kaen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determined effects of BreatheMAX on secretion clearance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease
Keywords
BreatheMAX breathing device, Secretion clearance, Ventilatory dependence, Intubated patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
breathing exercise
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
BreatheMAX breathing device
Intervention Description
secretion clearance, breathing exercise
Primary Outcome Measure Information:
Title
secretion wet weight (gram)
Description
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.)
Title
viscosity of secretion
Description
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 Outcome Measure Information:
Title
Heart rate (beat/min)
Description
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
Title
Oxygen saturation (%SpO2)
Description
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
Title
Respiratory rate (times/min)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
One sign of secretion accumulation in bronchi
Stable cardiopulmonary function
Good consciousness and good co-operation
Exclusion Criteria:
Massive hemoptysis
Pneumothorax (untreated)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miss Sujittra Kluayhomthong, Bachelor
Phone
081-379-0647
Email
rabbit_tigger@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mrs. Chulee Jones, Philosophy
Phone
664-320-2399
Email
Chujones46@yahoo.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sujittra Kluayhomthong, Bachelor
Organizational Affiliation
Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chulee CU Jones, Philosophy
Organizational Affiliation
Physical Therapy Department, Faculty of Associated Medical Sciences, Khon Kaen university, Thailand
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wilaiwan Khrisanapant, Philosophy
Organizational Affiliation
Department of physiology, Faculty of medicine, Khon Kaen university
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujittra Kluayhomthong, Bachelor
Phone
668-139-0647
Email
rabbit_tigger@hotmail.com
First Name & Middle Initial & Last Name & Degree
Chulee CU Jones, Philosophy
Phone
664-320-2399
Email
chujones46@yahoo.co.uk
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance
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