An interventional study of bubble PEP in Chronic Obstructive Pulmonary Disease With Exacerbation, Chronic Obstructive Pulmonary Disease Exacerbation and Chronic Pulmonary Disease, sponsored by National Taipei University of Nursing and Health Sciences. Terminated at 1 site in Taiwan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by National Taipei University of Nursing and Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 57 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →National Taipei University of Nursing and Health Sciences is the lead sponsor of 123 studies on the registry; 23 are open to participants now.
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The experimental group receives the Bubble PEP training.
Device: bubble PEP
The control group receives the division of chest ward routine care.
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.
The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT)
In the CAT, a total of eight items were used to assess the degree of dyspnea of the patients. Each item had a score ranging from 0 to 5 points, with the lowest total score being 0 points and the highest total score being 40 points. The higher the score, the higher the degree of dyspnea.
Time frame: 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.
The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ)
CSSAQ is used to assess patients' cough and sputum symptoms. The questionnaire content is based on published literature. It consists of 25 questions, including issues related to cough, sputum, and psychological symptoms and impacts. The scoring uses a four-point Likert scale, with scores ranging from 0 to 4, where higher scores indicate more severe symptoms. The total scale score ranges from a minimum of 0 to a maximum of 100. The content validity index is 1, and the Cronbach's α is 0.97.
Time frame: 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.
Peak Expiratory Flow Rate(PEFR)
The TruZone peak flow meter is used to monitor the patient's Forced Expiratory Volume in the first second (FEV1). For each data collection session, three maximum expiratory flow tests are conducted, and the best value is taken as the result for that session. The measurement unit is ml/sec.
Time frame: 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.
Re-hospitalization Event
The number of patients who were readmitted due to COPD acute exacerbation (COPDAE) within 14 days after discharge during the study.
Time frame: Within 14 days after discharge.
The study data were collected from February 2021 to July 2021 at two teaching hospitals in northern Taiwan.
| Milestone | Bubble Positive Expiratory Pressure Training | General Care |
|---|---|---|
| Started | 13 | 14 |
| Completed | 8 | 4 |
| Not completed | 5 | 10 |
| Withdrew: Stay-at-home during a covid-19 outbreak | 1 | 3 |
| Withdrew: Lost to follow-up | 2 | 6 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Admitted due to pneumothorax. | 1 | 0 |
| Withdrew: Admitted due to hivd for operation. | 0 | 1 |
In the CAT, a total of eight items were used to assess the degree of dyspnea of the patients. Each item had a score ranging from 0 to 5 points, with the lowest total score being 0 points and the highest total score being 40 points. The higher the score, the higher the degree of dyspnea.
| score on a scale | General Care Group | Intervention Group |
|---|---|---|
| T0 | 13 ± 6.33 | 19.77 ± 6.26 |
| T1 | 11.17 ± 8.04 | 13.18 ± 10.59 |
| T2 | 9.50 ± 9.26 | 9.63 ± 6.78 |
CSSAQ is used to assess patients' cough and sputum symptoms. The questionnaire content is based on published literature. It consists of 25 questions, including issues related to cough, sputum, and psychological symptoms and impacts. The scoring uses a four-point Likert scale, with scores ranging from 0 to 4, where higher scores indicate more severe symptoms. The total scale score ranges from a minimum of 0 to a maximum of 100. The content validity index is 1, and the Cronbach's α is 0.97.
| score on a scale | Bubble Positive Expiratory Pressure Training | General Care |
|---|---|---|
| T0 | 14.38 ± 10.46 | 27.00 ± 23.31 |
| T1 | 23.64 ± 20.92 | 29.83 ± 28.34 |
| T2 | 14.38 ± 10.46 | 27.00 ± 23.31 |
The TruZone peak flow meter is used to monitor the patient's Forced Expiratory Volume in the first second (FEV1). For each data collection session, three maximum expiratory flow tests are conducted, and the best value is taken as the result for that session. The measurement unit is ml/sec.
| ml/sec | Bubble Positive Expiratory Pressure Training | General Care |
|---|---|---|
| T0 | 320.00 ± 94.57 | 232.50 ± 85.00 |
| T1 | 250.45 ± 82.60 | 273.33 ± 89.14 |
| T2 | 320.00 ± 94.57 | 232.50 ± 85.00 |
The number of patients who were readmitted due to COPD acute exacerbation (COPDAE) within 14 days after discharge during the study.
| Number | Bubble Positive Expiratory Pressure Training | General Care |
|---|---|---|
| rehospitalization event | 0 | 0 |
| non rehospitalization event | 8 | 6 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bubble Positive Expiratory Pressure Training | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| General Care | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
A total of 27 participants in the study, 13 and 14 were assigned to the intervention and control groups, respectively. Two groups completed the sociodemographic characteristics and baseline test(T0).
| Age, Customized(Participants) | Bubble Positive Expiratory Pressure Training | General Care | Total |
|---|---|---|---|
| Age : < 70 | 6 | 4 | 10 |
| Age : >= 70 | 7 | 10 | 17 |
| Sex: Female, Male(Participants) | Bubble Positive Expiratory Pressure Training | General Care | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 12 | 13 | 25 |
| Race (NIH/OMB)(Participants) | Bubble Positive Expiratory Pressure Training | General Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 13 | 14 | 27 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Bubble Positive Expiratory Pressure Training | General Care | Total |
|---|---|---|---|
| Taiwan | 13 | 14 | 27 |
| Marital status(Participants) | Bubble Positive Expiratory Pressure Training | General Care | Total |
|---|---|---|---|
| divorced/Single | 5 | 4 | 9 |
| married | 8 | 10 | 18 |
| Occupation(Participants) | Bubble Positive Expiratory Pressure Training | General Care | Total |
|---|---|---|---|
| blue-collar worker | 7 | 10 | 17 |
| white-collar worker | 6 | 4 | 10 |
| Smoking history(Participants) | Bubble Positive Expiratory Pressure Training | General Care | Total |
|---|---|---|---|
| smoking | 3 | 4 | 7 |
| non-smoking | 1 | 1 | 2 |
| quit-smoking | 9 | 9 | 18 |
| Chronic comorbidities(Participants) | Bubble Positive Expiratory Pressure Training | General Care | Total |
|---|---|---|---|
| Hypertension | 6 | 7 | 13 |
| Diabetes mellitus | 1 | 2 | 3 |
| Heart disease | 6 | 6 | 12 |
| Pneumothorax | 0 | 2 | 2 |
| Lung cancer | 1 | 0 | 1 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Feb 2021 to primary completion in Aug 2021, 6 months.
Results were first posted in Dec 2024, 3 years 3 months after primary completion.
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