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

• ClinicalTrials.gov Identifier: NCT04828837
• Recruitment Status: Active, not recruiting
• First Posted: April 2, 2021
• Last Update Posted: April 2, 2021
• Sponsor: National Taipei University of Nursing and Health Sciences
• Information provided by (Responsible Party): SZU-YI WANG, National Taipei University of Nursing and Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease With Exacerbation; Chronic Obstructive Pulmonary Disease Exacerbation; Chronic Pulmonary Disease	Device: bubble PEP	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: National Taipei University of Nursing and Heath Sciences
• Actual Study Start Date: February 2, 2021
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Pulmonary function [ Time Frame: for one year ]
   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.

Secondary Outcome Measures :

1. Re-hospitalization risk [ Time Frame: for one year ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

Taiwan

National Taipei University of Nursing and Heath Sciences

Taipei City, Beitou District, Taiwan, 112303

Sponsors and Collaborators

National Taipei University of Nursing and Health Sciences

Investigators

• Principal Investigator: Szu Yi Wang; none, specify Unaffiliated

More Information

• Responsible Party: SZU-YI WANG, Principal Investigator, National Taipei University of Nursing and Health Sciences
• ClinicalTrials.gov Identifier: NCT04828837
• Other Study ID Numbers: SYWANG
• First Posted: April 2, 2021
• Last Update Posted: April 2, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SZU-YI WANG, National Taipei University of Nursing and Health Sciences:

COPD, Bubble PEP, pulmonary function

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Disease Progression; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes