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

NCT04828837 | Terminated Results

• 1 other identifier: SYWANG
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COPD, Bubble PEP, pulmonary function

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Re-hospitalization Event

  Within 14 days after discharge.

Study Arms (2)

Bubble positive expiratory pressure training

EXPERIMENTAL

The experimental group receives the Bubble PEP training.

Device: bubble PEP

general care

NO INTERVENTION

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

Interventions

bubble PEP 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.

Bubble positive expiratory pressure training

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients diagnosed with COPD
• Over 40 years old
• Awareness and ability to read articles
• Agree to participate in this research and sign the research consent form

You may not qualify if:

• Use non-invasive positive pressure breathing apparatus
• Have received positive pressure breathing therapy before or during hospitalization
• People with mental illness
• Coughing up blood, pneumothorax
• Suffer from legally infectious respiratory diseases
• Pregnant women
• Reject the subject

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

National Taipei University of Nursing and Heath Sciences

Taipei, Beitou District, 112303, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was affected by the COVID-19 pandemic. Due to the high attrition rate, our ITT results may have led to over- or underestimation of the effectiveness of the intervention. Sample size should therefore be increased in future studies. In addition, we used self-administered questionnaires for all measures except the PEFR test to evaluate intervention effectiveness.

Results Point of Contact

• Title: Wang Szu-Yi
• Organization: NTUNHS

jachiex@gmail.com

886-97140315

Study Officials

• Szu Yi Wang

  none, specify Unaffiliated

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: April 2, 2021
• Study Start: February 2, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: December 11, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)