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| Name | Class |
|---|---|
| Hill-Rom | INDUSTRY |
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The objective of this study was to evaluate the use of high frequency chest wall oscillation (HFCWO) early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD).
Acute asthma and chronic obstructive pulmonary disease (COPD) are exceedingly common, which together account for nearly 1 million hospitalizations each year in the United States alone. Beta agonists, anticholinergics, and corticosteroids delivered in aerosolized forms (via respiratory inhalers or nebulization) are recommended in the treatment of acute asthma and COPD. These medications rely on deposition into distal airspaces to suppress airway inflammation or promote bronchodilation. Unfortunately, excessive mucous production and impaired airway mucociliary clearance can lead to airway plugging, and thereby reduce the deposition of and response to aerosolized medications. These considerations highlight the need for therapies that clear airways of mucus in the acute management of asthma and COPD. High frequency chest wall oscillation (HFCWO) creates high velocity, low amplitude oscillatory airflows when applied through a pneumatic vest worn over the thorax, and is used for airway mucus clearance in patients with cystic fibrosis, bronchiectasis, and neuromuscular disorders.
This was a randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham high frequency chest wall oscillation | Sham Comparator | Sham high frequency chest wall oscillation |
|
| Active high frequency chest wall oscillation | Active Comparator | Active high frequency chest wall oscillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Frequency Chest Wall Oscillator | Device | High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Adherence to High Frequency Chest Wall Oscillation | Patient adherence to therapy after four treatments. | After four treatments of 15 minutes each |
| Number of Participants Who Considered the Pneumatic Vest Convenient to Use | The study vest was convenient to use. | After four treatments of 15 minutes each |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry A Krishnan, MD, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Hospital and Medical Center | Chicago | Illinois | 60616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21906390 | Derived | Mahajan AK, Diette GB, Hatipoglu U, Bilderback A, Ridge A, Harris VW, Dalapathi V, Badlani S, Lewis S, Charbeneau JT, Naureckas ET, Krishnan JA. High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial. Respir Res. 2011 Sep 10;12(1):120. doi: 10.1186/1465-9921-12-120. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham High Frequency Chest Wall Oscillation | Sham high frequency chest wall oscillation. High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax |
| FG001 | Active High Frequency Chest Wall Oscillation | High frequency chest wall oscillation High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham High Frequency Chest Wall Oscillation | Sham high frequency chest wall oscillation High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax |
| BG001 | Active High Frequency Chest Wall Oscillation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Adherence to High Frequency Chest Wall Oscillation | Patient adherence to therapy after four treatments. | Posted | Mean | Standard Deviation | Percent of 60 minutes prescribed | After four treatments of 15 minutes each |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham High Frequency Chest Wall Oscillation | Sham high frequency chest wall oscillation High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerry A. Krishnan | University of Illinois at Chicago | 312-413-0637 | jakris@uic.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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High frequency chest wall oscillation High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Sex/Gender was not collected from any participant. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants Who Considered the Pneumatic Vest Convenient to Use | The study vest was convenient to use. | 1 participant in the Sham group and 1 participant in the Active group had missing data for the question regarding the convenience of the pneumatic vest, therefore these participants were not included in the number analyzed for the outcome measure data table below. | Posted | Count of Participants | Participants | After four treatments of 15 minutes each |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Active High Frequency Chest Wall Oscillation | Active high frequency chest wall oscillation High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax | 0 | 25 | 0 | 25 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |