Bubble PEP Training Among Patient With Chronic Obstructive Pulmonary Disease in Pulmonary Function Effects

Chronic Obstructive Pulmonary Disease Exacerbation Clinical Trial

Official title:

National Taipei University of Nursing and Heath Sciences

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04828837
• Other study ID #: SYWANG
• Status: Terminated
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: April 2022
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The morbidity rate of Chronic Obstructive Pulmonary Disease (COPD) is increasing year by year. It is predicted to be the third leading cause of death worldwide in 2030. People with COPD have a high risk of needing a ventilator due to the decline of lung function, the increase of secretions, the dysfunction of airway clearance, and the obstruction and loss of alveolar elasticity.

Description:

This study aimed to explore the effectiveness of cough and sputum assessment and respiratory physiological indicators after training with the Bubble positive expiratory pressure (Bubble PEP) inpatients with COPD. This is a randomization control trial design survey using convenient sampling and will be to select 94 inpatients with COPD in the division of chest ward of two teaching hospital in New Taipei City. The subjects who meet the conditions for admission are explained, and they need to sign a consent form confirming that they understand the risks. More, they are randomly divided into the experimental group (experimental group n=47) and the control group (control group n=47). The experimental group receives the Bubble PEP training; the control group receives the division of chest ward routine care. The study employs a structured questionnaire including a basic demography, COPD domain, COPD assessment test (CAT), cough and sputum assessment test, and check the peak expiratory flow rate (PEFR) using it for data collection. The study needs to be approve by the Institutional Review Board. The two groups agreed to participate in the study, after completing the subject consent form before the intervention, they also received the pre-test as a benchmark for the intervention effect. After completing the 7-day and 30-day intervention, the post-test was performed immediately to understand the intervention immediate effect.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Hospitalized patients diagnosed with COPD

2. Over 40 years old

3. Awareness and ability to read articles

4. Agree to participate in this research and sign the research consent form

Exclusion Criteria:

1. Use non-invasive positive pressure breathing apparatus

2. Have received positive pressure breathing therapy before or during hospitalization

3. People with mental illness

4. Coughing up blood, pneumothorax

5. Suffer from legally infectious respiratory diseases

6. Pregnant women

7. Reject the subject

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Exacerbation
• Chronic Obstructive Pulmonary Disease With Exacerbation
• Chronic Pulmonary Disease
• Disease Progression
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• bubble PEP
Using the bubble positive expiratory pressure (Bubble PEP) for breathing training of inpatients with COPD. The training course for one day of three times. Every time needs about 20 mins. Huff and cough after the breathing training the end.

Locations

Country	Name	City	State
Taiwan	National Taipei University of Nursing and Heath Sciences	Taipei City	Beitou District

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function	I hope the breathing exercise can to improving the COPDAE in-patients pulmonary function. I would like to use two kinds of questionnaires and a total of 43 questions, and PEFR to monitor pulmonary function, which includes the efficacy of cough improvement, sputum clearance, and airway obstruction symptoms. Furthermore, I will follow up to study one day, the 7th, and the 30th day.	for one year
Secondary	Re-hospitalization risk	I hope the breathing exercise can reduce the chronic obstructive pulmonary disease acute exacerbation in-patients the re-hospitalization risk. Therefore, I will follow the patient every week between discharge till the 30th day.	for one year