Lung DiseasePhase 2/3ESMOSCNCT01090804
The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance
A Phase 2/3 study testing BreatheMAX breathing device in people with Lung Disease, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to determined effects of BreatheMAX on secretion clearance. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Lung Disease
- What is being tested?
- BreatheMAX breathing device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2009to Dec 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- One sign of secretion accumulation in bronchi
- Stable cardiopulmonary function
- Good consciousness and good co-operation
Who cannot join
- Massive hemoptysis
- Pneumothorax (untreated)
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University
Muang, Changwat Khon Kaen, 40002
Sujittra Kluayhomthong, Bachelor, 668-139-0647, rabbit_tigger@hotmail.com
Chulee CU Jones, Philosophy, 664-320-2399, chujones46@yahoo.co.uk
About this study
Official title: The Effectiveness of BreatheMAX Breathing Device on Airway Secretion Clearance in Patients With Ventilatory Dependence
The purpose of this study is to determined effects of BreatheMAX on secretion clearance.
- Conditions
- Lung Disease
- Being tested
- BreatheMAX breathing device
- Keywords
- BreatheMAX breathing device, Secretion clearance, Ventilatory dependence, Intubated patients
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreatheMAX breathing deviceDevice
secretion clearance, breathing exercise
| Study group | Role | What they receive |
|---|---|---|
| breathing exercise | Experimental | 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 Receives: Device: BreatheMAX breathing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three hours before, ten hours after treatment and night-time (02.00-07.00 am.)
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).
Measured: Three hours before and after treatment
Secondary outcomes (3)
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)
Measured: Before, during breathing exercise with device and immediate after treatment
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)
Measured: Before, during breathing exercise with device and immediate after treatment
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)
Measured: In rest interval between set (1 minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- Sujittra Kluayhomthong, Bachelor, Study chair, Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen universityChulee CU Jones, Philosophy, Study director, Physical Therapy Department, Faculty of Associated Medical Sciences, Khon Kaen university, ThailandWilaiwan Khrisanapant, Philosophy, Study director, Department of physiology, Faculty of medicine, Khon Kaen university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090804
- Sponsor's protocol ID
- 47660279
- Acronym
- ESMOSC
- Status last verified
- Jan 2010
- First submitted
- 7 Jan 2010
- Last updated
- 23 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of BreatheMAX Breathing Device on Airway Secretion Clearance in Patients With Ventilatory Dependence
- ClinicalTrials.gov ID
- NCT01090804
- Acronym / sponsor ID
- ESMOSC / 47660279
- Conditions
- Lung Disease
- Keywords
- BreatheMAX breathing device, Secretion clearance, Ventilatory dependence, Intubated patients
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- First posted
- 23 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determined effects of BreatheMAX on secretion clearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breathing exercise | Experimental | Device: BreatheMAX breathing deviceBreatheMAX 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 |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- One sign of secretion accumulation in bronchi
- Stable cardiopulmonary function
- Good consciousness and good co-operation
Key exclusion criteria (2 listed)
- Massive hemoptysis
- Pneumothorax (untreated)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreatheMAX breathing devicesecretion clearance, breathing exercise | Device | breathing exercise |
Primary outcome
secretion wet weight (gram)
Time frame: Three hours before, ten hours after treatment and night-time (02.00-07.00 am.)
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
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).
3 secondary outcomes
Heart rate (beat/min)
Time frame: Before, during breathing exercise with device and immediate after treatment
Oxygen saturation (%SpO2)
Time frame: Before, during breathing exercise with device and immediate after treatment
Respiratory rate (times/min)
Time frame: In rest interval between set (1 minute)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BreatheMAX breathing device in people with Lung Disease, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miss Sujittra Kluayhomthong, Bachelor (081-379-0647, rabbit_tigger@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
secretion wet weight (gram) (time frame: Three hours before, ten hours after treatment and night-time (02.00-07.00 am.)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2010.