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

National Taipei University of Nursing and Heath Sciences

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pulmonary Disease; Chronic Obstructive Pulmonary Disease Exacerbation; Chronic Obstructive Pulmonary Disease With Exacerbation
• Intervention / Treatment: Device: bubble PEP

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Beitou District
    • Taipei City, Beitou District, Taiwan, 112303
      • National Taipei University of Nursing and Heath Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bubble positive expiratory pressure training; The experimental group receives the Bubble PEP training.	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.
No Intervention: general care; The control group receives the division of chest ward routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-hospitalization Event	The number of patients who were readmitted due to COPD acute exacerbation (COPDAE) within 14 days after discharge during the study.	Within 14 days after discharge.

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Investigators: Principal Investigator: Szu Yi Wang, none, specify Unaffiliated

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: COPD, Bubble PEP, pulmonary function
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Disease Progression
• Other Study ID Numbers: SYWANG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No