Chronic Obstructive Pulmonary Disease Exacerbation, Chronic Obstructive Pulmonary Disease With Exacerbation, Chronic Pulmonary Disease
Conditions
Keywords
COPD, Bubble PEP, pulmonary function
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.
Interventions
DEVICEbubble 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.
Sponsors
National Taipei University of Nursing and Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT) | 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. | 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 Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ) | 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. | 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. |
| Peak Expiratory Flow Rate(PEFR) | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-hospitalization Event | Within 14 days after discharge. | The number of patients who were readmitted due to COPD acute exacerbation (COPDAE) within 14 days after discharge during the study. |
Countries
Taiwan
Participant flow
Recruitment details
The study data were collected from February 2021 to July 2021 at two teaching hospitals in northern Taiwan.
Pre-assignment details
In the study, 30 patients were excluded from the study before assignment to groups4 patients declined to participate, 10 inpatients had used non-invasive PEP treatment before hospitalization, 4 patients has a mental illness, and 12 patients have notifiable respiratory infectious diseases.
Participants by arm
| Arm | Count |
|---|---|
| Bubble Positive Expiratory Pressure Training GOLD: Global Initiative for Chronic Obstructive Lung Disease; a Baseline (T0) data conduct homogenous test; Fisher's exact: Gander, Age, Marital status, Occupation, Smoking history, chronic comorbidities, diabetes mellitus, pneumothorax, lung cancer, COPD Grade | 13 |
| General Care GOLD: Global Initiative for Chronic Obstructive Lung Disease; a Baseline (T0) data conduct homogenous test; Fisher's exact: Gander, Age, Marital status, Occupation, Smoking history, chronic comorbidities, diabetes mellitus, pneumothorax, lung cancer, COPD Grade | 14 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Admitted due to HIVD for operation. | 0 | 1 |
| Overall Study | Admitted due to pneumothorax. | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 6 |
| Overall Study | Stay-at-home during a COVID-19 outbreak | 1 | 3 |
Baseline characteristics
| Characteristic | Bubble Positive Expiratory Pressure Training | General Care | Total |
|---|---|---|---|
| Age, Customized Age : < 70 | 6 Participants | 4 Participants | 10 Participants |
| Age, Customized Age : >= 70 | 7 Participants | 10 Participants | 17 Participants |
| Chronic comorbidities Diabetes mellitus | 1 Participants | 2 Participants | 3 Participants |
| Chronic comorbidities Heart disease | 6 Participants | 6 Participants | 12 Participants |
| Chronic comorbidities Hypertension | 6 Participants | 7 Participants | 13 Participants |
| Chronic comorbidities Lung cancer | 1 Participants | 0 Participants | 1 Participants |
| Chronic comorbidities Pneumothorax | 0 Participants | 2 Participants | 2 Participants |
| COPD Grade GOLD 2(FEV1 50-79) | 2 Participants | 6 Participants | 8 Participants |
| COPD Grade GOLD 3(FEV1 30-49) | 11 Participants | 8 Participants | 19 Participants |
| Dry powder bronchodilator use (day) | 7.25 days STANDARD_DEVIATION 4.31 | 3.30 days STANDARD_DEVIATION 2.41 | 5.45 days STANDARD_DEVIATION 4 |
| Marital status divorced/Single | 5 Participants | 4 Participants | 9 Participants |
| Marital status married | 8 Participants | 10 Participants | 18 Participants |
| Occupation blue-collar worker | 7 Participants | 10 Participants | 17 Participants |
| Occupation white-collar worker | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 14 Participants | 27 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 13 participants | 14 participants | 27 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
| Smoking history non-smoking | 1 Participants | 1 Participants | 2 Participants |
| Smoking history quit-smoking | 9 Participants | 9 Participants | 18 Participants |
| Smoking history smoking | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
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.
Population: A total of 57 were randomly assigned and complete test, with 13 in the experimental group and 14 in the control group. At T1, the experimental group had 11 analyzed, experiencing a total loss of 2 participants. In comparison, the control group had 6 analyzed at T1, with a cumulative loss of 8 participants. Moving to T2, the experimental group had 8 analyzed, with a total loss of 3 participants. The control group had 4 analyzed at T2, with a cumulative loss of 2 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| General Care Group | Peak Expiratory Flow Rate(PEFR) | T1 | 250.45 ml/sec | Standard Deviation 82.6 |
| General Care Group | Peak Expiratory Flow Rate(PEFR) | T2 | 320.00 ml/sec | Standard Deviation 94.57 |
| General Care Group | Peak Expiratory Flow Rate(PEFR) | T0 | 320.00 ml/sec | Standard Deviation 94.57 |
| Intervention Group | Peak Expiratory Flow Rate(PEFR) | T0 | 232.50 ml/sec | Standard Deviation 85 |
| Intervention Group | Peak Expiratory Flow Rate(PEFR) | T1 | 273.33 ml/sec | Standard Deviation 89.14 |
| Intervention Group | Peak Expiratory Flow Rate(PEFR) | T2 | 232.50 ml/sec | Standard Deviation 85 |
Comparison: Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.p-value: <0.05The generalized estimating equation (GEE
Primary
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.
Population: A total of 57 were randomly assigned and complete test, with 13 in the experimental group and 14 in the control group. At T1, the experimental group had 11 analyzed, experiencing a total loss of 2 participants. In comparison, the control group had 6 analyzed at T1, with a cumulative loss of 8 participants. Moving to T2, the experimental group had 8 analyzed, with a total loss of 3 participants. The control group had 4 analyzed at T2, with a cumulative loss of 2 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| General Care Group | The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT) | T0 | 13 score on a scale | Standard Deviation 6.33 |
| General Care Group | The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT) | T1 | 11.17 score on a scale | Standard Deviation 8.04 |
| General Care Group | The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT) | T2 | 9.50 score on a scale | Standard Deviation 9.26 |
| Intervention Group | The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT) | T0 | 19.77 score on a scale | Standard Deviation 6.26 |
| Intervention Group | The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT) | T1 | 13.18 score on a scale | Standard Deviation 10.59 |
| Intervention Group | The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT) | T2 | 9.63 score on a scale | Standard Deviation 6.78 |
Comparison: Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
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.
Population: A total of 57 were randomly assigned and complete test, with 13 in the experimental group and 14 in the control group. At T1, the experimental group had 11 analyzed, experiencing a total loss of 2 participants. In comparison, the control group had 6 analyzed at T1, with a cumulative loss of 8 participants. Moving to T2, the experimental group had 8 analyzed, with a total loss of 3 participants. The control group had 4 analyzed at T2, with a cumulative loss of 2 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| General Care Group | The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ) | T0 | 14.38 score on a scale | Standard Deviation 10.46 |
| General Care Group | The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ) | T1 | 23.64 score on a scale | Standard Deviation 20.92 |
| General Care Group | The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ) | T2 | 14.38 score on a scale | Standard Deviation 10.46 |
| Intervention Group | The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ) | T0 | 27.00 score on a scale | Standard Deviation 23.31 |
| Intervention Group | The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ) | T1 | 29.83 score on a scale | Standard Deviation 28.34 |
| Intervention Group | The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ) | T2 | 27.00 score on a scale | Standard Deviation 23.31 |
Comparison: Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.p-value: <0.05The generalized estimating equation (GEE
Secondary
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| General Care Group | Re-hospitalization Event | rehospitalization event | 0 Number |
| General Care Group | Re-hospitalization Event | non rehospitalization event | 8 Number |
| Intervention Group | Re-hospitalization Event | rehospitalization event | 0 Number |
| Intervention Group | Re-hospitalization Event | non rehospitalization event | 6 Number |
p-value: <0.05Chi-squared