OPEP Devices in Acute Inpatient Treatment of Pneumonia

Study Overview
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Brief Summary
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This is a randomized-controlled prospective study to be conducted at Danbury Hospital and Norwalk Hospital to evaluate oscillatory positive expiratory pressure (OPEP) devices for airway clearance (helping to clear out phlegm or mucous from your lungs and bronchial tubes) in the treatment of patients admitted to the hospital with pneumonia. Approximately 200 subjects are expected to participate in this study.

Detailed Description
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Pneumonia is one of the most common health conditions leading to hospitalization today. Approximately 1.3 million people in the US are admitted to the hospital with community-acquired pneumonia (CAP) annually, with readmission rates within the first 30 days as high as 20%. In a retrospective analysis of patients with culture-confirmed bacterial pneumonia, 30-day readmission occurred in 19.3% of patients. At Norwalk Hospital, the 30-day readmission rate for patients with pneumonia is 13.1%. CAP is the sixth most common cause of death with a case-fatality rate of up to 16% for hospitalized CAP patients, and an overall 30-day mortality up to 23%. The economic burden of CAP is also high, l with a CAP cost burden estimated to be at least $13 billion in 2008 within just the Medicare population. There have been several small studies done to analyze the utility of airway clearance and its potential role in CAP. These studies have generally been small and have used a wide variety of airway clearance devices and techniques, including external chest wall physiotherapy devices and postural drainage, both now considered second line therapies for most patients. These studies have been variable in their findings and overall have not shown that airway clearance is either beneficial or harmful in CAP. The studies did show, however, that the duration of fever and hospital length of stay were both significantly decreased, suggesting the possibility of other clinically important benefits. In this prospective randomized controlled trial, investigators will test the hypothesis that the use of OPEP devices, specifically the handheld Aerobika (Monaghan Medical) will result in more rapid and durable recovery in patients hospitalized with community-acquired pneumonia as measured by decreased hospital length of stay, reduced duration of fever, improvement in dyspnea, decreased duration of antibiotics, increased rate of diagnosis of the etiologic organism responsible for the pneumonia, and reduced readmission rates: Primary outcome 1. Reduction in hospital length of stay Secondary outcomes Reduction in dyspnea by modified-Borg score Reduction in duration of antibiotics Reduction in duration of fever Reduction in need for oxygen at hospital discharge Reduction in 30-, 60-, and 90-day readmission rates Diagnosis of organism by sputum Transfer to the intensive care unit (ICU)

Official Title
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Oscillatory Positive Expiratory Pressure Devices in Acute Inpatient Treatment of Pneumonia

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Device: OPEP therapy
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical symptoms suggesting pneumonia (eg. cough, fever, pleuritic chest pain, sputum production, dyspnea) Any new chest radiographic infiltrate consistent with pneumonia Exclusion Criteria: Untreated or recently (within the past 90 days) treated pneumothorax Active hemoptysis Recent facial, oral, or skull trauma Hemodynamically unstable patients Severe nausea or active vomiting Recent diagnosis of pneumonia prior to current inpatient encounter (within 60 days) Significant cognitive impairment or psychiatric conditions that prevent ability to participate in or cooperate with oPEP use Active TB or in negative pressure room Pregnancy Pre-existing medical condition with a life expectancy of less than 3 months Inability to form appropriate mouth seal on device (eg. due to neuromuscular disease) Pre-existing active use of oPEP devices Requiring >=50% FiO2 or facemask (excluding high flow NC)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients randomized to the OPEP therapy added to standard pneumonia care OR standard pneumonia care..
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OPEP therapy added to standard pneumonia care<br>The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia. | Device: OPEP therapy<br>* Oscillatory Positive Expiratory Pressure therapy<br>Other: Standard care<br>* Standard pneumonia care<br>|
| Active Comparator: Standard pneumonia care<br>The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia. | Other: Standard care<br>* Standard pneumonia care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | Number of days that the patient stays in hospital was collected from medical record. We have calculated the mean and the standard deviation for both groups. | duration of hospital stay, an expected average of 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported Dyspnea by Modified-Borg Score | Dyspnea as measured by modified-Borg score, minimum value 0 (No shortness of breath) and maximum value 10 (Maximal breathlessness). Score scale is from 0-10. We have calculated the mean and the standard deviation for both groups. | duration of hospital stay, an expected average of 4 days | 
| Duration of Antibiotics | Duration of antibiotics was collected from medical record. We have calculated the mean and the standard deviation for both groups. | duration of hospital stay, an expected average of 4 days | 
| Duration of Fever | Duration of fever was collected from medical record. We have calculated the mean and the standard deviation for both groups. | duration of hospital stay, an expected average of 4 days | 
| Number of Participants With Need for Oxygen Supplement at Hospital Discharge | Number of participants with need for oxygen supplement at the time of hospital discharge was collected from medical record for both groups. | duration of hospital stay, an expected average of 4 days | 
| Reported 30-, 60-, and 90-day Readmission Rates | Number of total hospital readmissions post-enrollment was obtained from medical record. | 90 day after the hospital discharge | 
| Number of Participants With Positive Sputum Culture | Data on the diagnosis of organism by sputum (positive sputum culture) was collected from medical record. We have counted number of participants with intervention and without intervention. | duration of hospital stay, an expected average of 4 days | 
| Number of Participants Transferred to the Intensive Care Unit (ICU) | Number of participants transferred to the intensive care unit post enrollment was obtained from medical record for both groups. | duration of hospital stay, an expected average of 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oscillatory positive expiratory pressure