OPEP Devices in Acute Inpatient Treatment of Pneumonia

Not Applicable

Terminated

Conditions: Community-acquired Pneumonia

Interventions: Device: OPEP therapy
Other: Standard care

Registration Number: NCT04540510

Lead Sponsor: Danbury Hospital

Brief Summary: 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: 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

1. Reduction in dyspnea by modified-Borg score

2. Reduction in duration of antibiotics

3. Reduction in duration of fever

4. Reduction in need for oxygen at hospital discharge

5. Reduction in 30-, 60-, and 90-day readmission rates

6. Diagnosis of organism by sputum

7. Transfer to the intensive care unit (ICU)

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 11

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPEP therapy added to standard pneumonia care	OPEP therapy	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.
OPEP therapy added to standard pneumonia care	Standard care	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.
Standard pneumonia care	Standard care	The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.

Primary Outcome Measures

Name	Time	Method
Length of Hospital Stay	duration of hospital stay, an expected average of 4 days	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.

Secondary Outcome Measures

Name	Time	Method
Reported 30-, 60-, and 90-day Readmission Rates	90 day after the hospital discharge	Number of total hospital readmissions post-enrollment was obtained from medical record.
Number of Participants With Need for Oxygen Supplement at Hospital Discharge	duration of hospital stay, an expected average of 4 days	Number of participants with need for oxygen supplement at the time of hospital discharge was collected from medical record for both groups.
Duration of Fever	duration of hospital stay, an expected average of 4 days	Duration of fever was collected from medical record. We have calculated the mean and the standard deviation for both groups.
Number of Participants Transferred to the Intensive Care Unit (ICU)	duration of hospital stay, an expected average of 4 days	Number of participants transferred to the intensive care unit post enrollment was obtained from medical record for both groups.
Reported Dyspnea by Modified-Borg Score	duration of hospital stay, an expected average of 4 days	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 Antibiotics	duration of hospital stay, an expected average of 4 days	Duration of antibiotics was collected from medical record. We have calculated the mean and the standard deviation for both groups.
Number of Participants With Positive Sputum Culture	duration of hospital stay, an expected average of 4 days	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.