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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
Effective strategies to increase mucus clearance rate has been suggested to depend on 4 factors.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BreatheMAX (OPEP) | Active Comparator | for 10 breathes/set, 10 sets/day and rest 1 minute between set |
|
| BreatheMAX (OIS and OPEP) | Experimental | for 10 breathes/set, 10 sets/day and rest 1 minute between set |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BreatheMAX (OPEP) | Device | for 10 breathes/set, 10 sets/day and rest 1 minute between set |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in dynamic compliance (Cdyn) at end of breathing exercise program |
| within 30 minutes before breathing exercise and 30 minute after breathing exercise |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chulee Jones, PhD | The Faculty of Associated Medical Sciences Khon Kaen University 123 Moo 16 Mittapap Road Nai-Muang, Muang District Khon Kaen 40002, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sujittra Kluayhomthong | Khon Kaen | 40002 | Thailand |
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| 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 |
|
| change from baseline in peak inspiratory pressure (PIP) at end of breathing exercise program |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 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 | 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 | 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 | 5 minutes before breathing exercise and 5 minute after breathing exercise |