Bronchial Secretion Retention Clinical Trial
— BMACPFOfficial 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
| NCT number | NCT02553200 |
| Other study ID # | KKU |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2016 |
| Est. completion date | February 28, 2018 |
| Verified date | December 2015 |
| Source | Khon Kaen University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | February 28, 2018 |
| Est. primary completion date | February 28, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Pneumothorax (nontreated) - Massive hemoptysis - Acute myocardial infarction (with angina chest pain) - High intracranial pressure (>20 mm Hg) - Major arrhythmia |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Sujittra Kluayhomthong | Khon Kaen |
| Lead Sponsor | Collaborator |
|---|---|
| Khon Kaen University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 |
within 30 minutes before breathing exercise and 30 minute after breathing exercise | |
| Secondary | 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 |
within 30 minutes before breathing exercise and 30 minute after breathing exercise | |
| Secondary | 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 |
within 30 minutes before breathing exercise and 30 minute after breathing exercise | |
| Secondary | 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 |
within 30 minutes before breathing exercise and 30 minute after breathing exercise | |
| Secondary | 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 |
within 30 minutes before breathing exercise and 30 minute after breathing exercise | |
| Secondary | 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 |
within 30 minutes before breathing exercise and 30 minute after breathing exercise | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | change from baseline in blood pressure at the end of breathing exercise program | 5 minutes before breathing exercise and 5 minute after breathing exercise |