Bronchial Secretion RetentionBMACPFNCT02553200
The Efficacy of Breathing Exercise With BreatheMAX Device on Airway Secretion Clearance and Lung Function
A study testing BreatheMAX (OPEP), BreatheMAX (OIS and OPEP) and BreatheMAX (unload and non-oscillated) in people with Bronchial Secretion Retention, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The efficacy of breathing exercise with oscillated inspiratory loading and oscillated positive expiratory pressure for airway secretion clearance and lung function in intubated patients, both with and without mechanical ventilation dependence Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchial Secretion Retention
- What is being tested?
- BreatheMAX (OPEP), BreatheMAX (OIS and OPEP) and BreatheMAX (unload and non-oscillated)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2016to 28 Feb 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following
- Clinical and radiologic diagnosis of pulmonary infection
- Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound
- Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data
- Stable of hydration status or positive fluid balance at least 2 days before collects the data
- Ability to breathe or tolerate spontaneously breathing trial with T-piece at least 2 minutes with fraction of inspired oxygen less than 0.4 and without developing hypoxemia
- Good conscious and well cooperation
Who cannot join
- Pneumothorax (nontreated)
- Massive hemoptysis
- Acute myocardial infarction (with angina chest pain)
- High intracranial pressure (>20 mm Hg)
- Major arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Breathing Exercise With Oscillated Inspiratory Loading (OIS) and Oscillated Positive Expiratory Pressure (OPEP) for Airway Secretion Clearance and Lung Function in Intubated Patients, Both With and Without Mechanical Ventilatory Support
The efficacy of breathing exercise with oscillated inspiratory loading and oscillated positive expiratory pressure for airway secretion clearance and lung function in intubated patients, both with and without mechanical ventilation dependence
Read the detailed description
Effective strategies to increase mucus clearance rate has been suggested to depend on 4 factors.
- Oscillation at proper frequency.
- Lung volume and airway opening.
- Expiratory flow rate or expiratory bias.
- Humidifying of inspired air.
Multifunctional breathing device, the BreatheMAX, is the only breathing device made in Thailand. The BreatheMAX device possess many properties or techniques that benefit for respiratory care particularly 3 in 4 mechanisms for secretion clearance. The unique important aspect is the simultaneously providing several beneficial effects in one breath which are 1) Oscillation in the range of ciliary beat frequency 2) Biofeedback of respiratory effort that could encourage the deeper breathing performance, 3) Humidifier of inspired air, 4) Loaded breathing for inspiratory muscle training and generate PEP. These 4 functions would be very useful for increase secretion clearance particularly in more peripheral airway which are the most difficult to be cleared and be a risk of atelectasis and infection in patients with MV whose natural secretion clearance mechanisms are compromised, respiratory muscle weakness weak and low immunity.
Therefore, the combination of inspiratory and expiratory breathing exercise through the BreatheMAX breathing device may increase or promote more secretion clearance and improve lung function than expiratory breathing exercise alone in intubated patients, both with and without mechanical ventilation dependence
- Conditions
- Bronchial Secretion Retention
- Being tested
- BreatheMAX (OPEP), BreatheMAX (OIS and OPEP), BreatheMAX (unload and non-oscillated)
- Keywords
- intubated patients, secretion clearance, lung function, breathing exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreatheMAX (OPEP)Device
for 10 breathes/set, 10 sets/day and rest 1 minute between set
BreatheMAX (OIS and OPEP)Device
for 10 breathes/set, 10 sets/day and rest 1 minute between set
BreatheMAX (unload and non-oscillated)Device
for 10 breathes/set, 10 sets/day and rest 1 minute between set
| Study group | Role | What they receive |
|---|---|---|
| BreatheMAX (OPEP) | Active comparator | for 10 breathes/set, 10 sets/day and rest 1 minute between set Receives: Device: BreatheMAX (OPEP) |
| BreatheMAX (OIS and OPEP) | Experimental | for 10 breathes/set, 10 sets/day and rest 1 minute between set Receives: Device: BreatheMAX (OIS and OPEP) |
| BreatheMAX (unload and non-oscillated) | Sham comparator | inspiratory and expiratory breathing exercise for 10 breathes/set, 10 sets/day and rest 1 minute between set Receives: Device: BreatheMAX (unload and non-oscillated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in secretion wet weight (gram) between 3 hours before and after breathing exercise program
The mucus secretion will be collected by nursing staff using sterile suctioning technique via tracheostomy (TT) or endotracheal (ET) tube, without adding any saline or sterile water, the timing of suction procedure depend on the secretion sound in the ET and TT tube.
Measured: the secretion will be collected between 3 hours before start breathing exercise program and 3 hours after end of breathing exercise program in each day
Secondary outcomes (10)
change from baseline in dynamic compliance (Cdyn) at end of breathing exercise program
- as follows: Cdy, PIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response
- the data will be recorded from the mechanical ventilator monitoring during the patients breathing with mechanical ventilation (MV) at least 1 minute
Measured: within 30 minutes before breathing exercise and 30 minute after breathing exercise
change from baseline in peak inspiratory pressure (PIP) at end of breathing exercise program
- as follows: Cdy, PIP,VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response
- the data will be recorded from the mechanical ventilator monitoring during the patients breathing with mechanical ventilation at least 1 minute
Measured: within 30 minutes before breathing exercise and 30 minute after breathing exercise
change from baseline in expired minute ventilation (VE) at end of breathing exercise program
- as follows: Cdy, PIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response
- the wright respirometer will be connected with ET or TT tube during spontaneous breathing (off MV) for 1 minute, three measurement will be measured and rest 1 minute by using mechanical ventilation
Measured: within 30 minutes before breathing exercise and 30 minute after breathing exercise
change from baseline in slow vital capacity (SVC) at end of breathing exercise program
- as follows: Cdy, PIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response
- the wright respirometer will be connected with ET or TT tube during spontaneous breathing (off MV), three measurement will be measured and rest 1 minute by using mechanical ventilation
Measured: within 30 minutes before breathing exercise and 30 minute after breathing exercise
change from baseline in lung sound at the end of breathing exercise program
- as follows: Cdy, PIP, PNIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response
- the electronic stethoscope will be used to record the lung sound in each area during breathing with mechanical ventilation
Measured: within 30 minutes before breathing exercise and 30 minute after breathing exercise
change from baseline in Rating of Perceived Exertion (RPE) and Rating of Perceived Breathlessness (RPB) at the end of breathing exercise program
- as follows: Cdy, PIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response
- using the dyspnea and exertion scale
Measured: within 30 minutes before breathing exercise and 30 minute after breathing exercise
change from baseline in heart rate at the end of breathing exercise program
the data will be recorded every minute
Measured: 5 minutes before breathing exercise and during breathing exercise and 5 minute after breathing exercise
change from baseline in partial pressure of oxygen saturation at the end of breathing exercise program
the data will be recorded every minute
Measured: 5 minutes before breathing exercise and during breathing exercise and 5 minute after breathing exercise
change from baseline in respiratory rate at the end of breathing exercise program
the data will be recorded every minute
Measured: 5 minutes before breathing exercise and during breathing exercise and 5 minute after breathing exercise
change from baseline in blood pressure at the end of breathing exercise program
Measured: 5 minutes before breathing exercise and 5 minute after breathing exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJan 2016
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial Secretion RetentionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sujittra Kluayhomthong, Khon Kaen University
- Investigators
- Chulee Jones, PhD, Principal investigator, The Faculty of Associated Medical Sciences Khon Kaen University 123 Moo 16 Mittapap Road Nai-Muang, Muang District Khon Kaen 40002, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553200
- Sponsor's protocol ID
- KKU
- Acronym
- BMACPF
- Status last verified
- Dec 2015
- First submitted
- 13 May 2015
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Breathing Exercise With Oscillated Inspiratory Loading (OIS) and Oscillated Positive Expiratory Pressure (OPEP) for Airway Secretion Clearance and Lung Function in Intubated Patients, Both With and Without Mechanical Ventilatory Support
- ClinicalTrials.gov ID
- NCT02553200
- Acronym / sponsor ID
- BMACPF / KKU
- Conditions
- Bronchial Secretion Retention
- Keywords
- intubated patients, secretion clearance, lung function, breathing exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 17 Sep 2015 (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 efficacy of breathing exercise with oscillated inspiratory loading and oscillated positive expiratory pressure for airway secretion clearance and lung function in intubated patients, both with and without mechanical ventilation dependence
Detailed description
Effective strategies to increase mucus clearance rate has been suggested to depend on 4 factors.
- Oscillation at proper frequency.
- Lung volume and airway opening.
- Expiratory flow rate or expiratory bias.
- Humidifying of inspired air.
Multifunctional breathing device, the BreatheMAX, is the only breathing device made in Thailand. The BreatheMAX device possess many properties or techniques that benefit for respiratory care particularly 3 in 4 mechanisms for secretion clearance. The unique important aspect is the simultaneously providing several beneficial effects in one breath which are 1) Oscillation in the range of ciliary beat frequency 2) Biofeedback of respiratory effort that could encourage the deeper breathing performance, 3) Humidifier of inspired air, 4) Loaded breathing for inspiratory muscle training and generate PEP. These 4 functions would be very useful for increase secretion clearance particularly in more peripheral airway which are the most difficult to be cleared and be a risk of atelectasis and infection in patients with MV whose natural secretion clearance mechanisms are compromised, respiratory muscle weakness weak and low immunity.
Therefore, the combination of inspiratory and expiratory breathing exercise through the BreatheMAX breathing device may increase or promote more secretion clearance and improve lung function than expiratory breathing exercise alone in intubated patients, both with and without mechanical ventilation dependence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BreatheMAX (OPEP) | Active comparator | Device: BreatheMAX (OPEP)for 10 breathes/set, 10 sets/day and rest 1 minute between set |
| BreatheMAX (OIS and OPEP) | Experimental | Device: BreatheMAX (OIS and OPEP)for 10 breathes/set, 10 sets/day and rest 1 minute between set |
| BreatheMAX (unload and non-oscillated) | Sham comparator | Device: BreatheMAX (unload and non-oscillated)inspiratory and expiratory breathing exercise for 10 breathes/set, 10 sets/day and rest 1 minute between set |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following
- Clinical and radiologic diagnosis of pulmonary infection
- Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound
- Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data
- Stable of hydration status or positive fluid balance at least 2 days before collects the data
Key exclusion criteria (5 listed)
- Pneumothorax (nontreated)
- Massive hemoptysis
- Acute myocardial infarction (with angina chest pain)
- High intracranial pressure (>20 mm Hg)
- Major arrhythmia
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 (OPEP)for 10 breathes/set, 10 sets/day and rest 1 minute between set | Device | BreatheMAX (OPEP) |
| BreatheMAX (OIS and OPEP)for 10 breathes/set, 10 sets/day and rest 1 minute between set | Device | BreatheMAX (OIS and OPEP) |
| BreatheMAX (unload and non-oscillated)for 10 breathes/set, 10 sets/day and rest 1 minute between set | Device | BreatheMAX (unload and non-oscillated) |
Primary outcome
change from baseline in secretion wet weight (gram) between 3 hours before and after breathing exercise program
Time frame: the secretion will be collected between 3 hours before start breathing exercise program and 3 hours after end of breathing exercise program in each day
The mucus secretion will be collected by nursing staff using sterile suctioning technique via tracheostomy (TT) or endotracheal (ET) tube, without adding any saline or sterile water, the timing of suction procedure depend on the secretion sound in the ET and TT tube.
10 secondary outcomes
change from baseline in dynamic compliance (Cdyn) at end of breathing exercise program
Time frame: within 30 minutes before breathing exercise and 30 minute after breathing exercise
change from baseline in peak inspiratory pressure (PIP) at end of breathing exercise program
Time frame: within 30 minutes before breathing exercise and 30 minute after breathing exercise
change from baseline in expired minute ventilation (VE) at end of breathing exercise program
Time frame: within 30 minutes before breathing exercise and 30 minute after breathing exercise
change from baseline in slow vital capacity (SVC) at end of breathing exercise program
Time frame: within 30 minutes before breathing exercise and 30 minute after breathing exercise
change from baseline in lung sound at the end of breathing exercise program
Time frame: within 30 minutes before breathing exercise and 30 minute after breathing exercise
change from baseline in Rating of Perceived Exertion (RPE) and Rating of Perceived Breathlessness (RPB) at the end of breathing exercise program
Time frame: within 30 minutes before breathing exercise and 30 minute after breathing exercise
change from baseline in heart rate at the end of breathing exercise program
Time frame: 5 minutes before breathing exercise and during breathing exercise and 5 minute after breathing exercise
change from baseline in partial pressure of oxygen saturation at the end of breathing exercise program
Time frame: 5 minutes before breathing exercise and during breathing exercise and 5 minute after breathing exercise
change from baseline in respiratory rate at the end of breathing exercise program
Time frame: 5 minutes before breathing exercise and during breathing exercise and 5 minute after breathing exercise
change from baseline in blood pressure at the end of breathing exercise program
Time frame: 5 minutes before breathing exercise and 5 minute after breathing exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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.
Chulee Jones, PhD principal investigator
The Faculty of Associated Medical Sciences Khon Kaen University 123 Moo 16 Mittapap Road Nai-Muang, Muang District Khon Kaen 40002, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BreatheMAX (OPEP), BreatheMAX (OIS and OPEP) and BreatheMAX (unload and non-oscillated) in people with Bronchial Secretion Retention, 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 17 Aug 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in secretion wet weight (gram) between 3 hours before and after breathing exercise program (time frame: the secretion will be collected between 3 hours before start breathing exercise program and 3 hours after end of breathing exercise program in each day). 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 17 Aug 2018.