Clinical trial NCT04828837: Bubble PEP Training Among Patient With Chronic Obstructive Pulmonary Disease in Pulmonary Function Effects
Official title: National Taipei University of Nursing and Heath Sciences
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease With Exacerbation
Chronic Obstructive Pulmonary Disease Exacerbation
Chronic Pulmonary Disease
Keywords: COPD, Bubble PEP, pulmonary function
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 57
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT)
timeFrame: The pre-tests within 48 hours of hospitalization, which served as the baseline of the intervention (T0). Assessed at 1(T1) and 4(T2) weeks, week 4 was reported.
measure: The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ)
timeFrame: The pre-tests within 48 hours of hospitalization, which served as the baseline of the intervention (T0). Assessed at 1(T1) and 4(T2) weeks, week 4 was reported.
measure: Peak Expiratory Flow Rate(PEFR)
timeFrame: The study lasted 30 days with a total of three measurements. The first measurement baseline was 48 hours after hospitalization, the second on day 7 of the study, and the third on day 30 of the study.
Secondary outcomes:
measure: Re-hospitalization Event
timeFrame: Within 14 days after discharge.
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taipei University of Nursing and Heath Sciences
state: Beitou District
Study officials:
affiliation: none, specify Unaffiliated
name: Szu Yi Wang
role: PRINCIPAL_INVESTIGATOR
References: