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

NCT ID: NCT04828837

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-02
• Study Completion Date: 2021-08-31

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.

Conditions

Chronic Obstructive Pulmonary Disease With Exacerbation; Chronic Obstructive Pulmonary Disease Exacerbation; Chronic Pulmonary Disease

Keywords

COPD, Bubble PEP, pulmonary function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bubble positive expiratory pressure training

The experimental group receives the Bubble PEP training.

Group Type: EXPERIMENTAL

bubble PEP

Intervention Type: DEVICE

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.

general care

The control group receives the division of chest ward routine care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

SZU-YI WANG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Szu Yi Wang

Role: PRINCIPAL_INVESTIGATOR

none, specify Unaffiliated

Locations

National Taipei University of Nursing and Heath Sciences

Taipei, Beitou District, Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SYWANG

Identifier Type: -

Identifier Source: org_study_id