An interventional study of OPEP therapy and Standard care in Community-acquired Pneumonia, sponsored by Danbury Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-24.
Sponsored by Danbury Hospital · Not applicable, Interventional, and Treatment
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.
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
Secondary outcomes
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 11 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Danbury Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: Standard care
The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Other: Standard care
Oscillatory Positive Expiratory Pressure therapy
Standard pneumonia care
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.
Time frame: duration of hospital stay, an expected average of 4 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: duration of hospital stay, an expected average of 4 days
| Milestone | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care |
|---|---|---|
| Started | 5 | 6 |
| Completed | 5 | 6 |
| Not completed | 0 | 0 |
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.
| days | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care |
|---|---|---|
| Length of Hospital Stay | 1.2 ± 0.9 | 4.0 ± 1.2 |
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.
| score on scale | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care |
|---|---|---|
| Reported Dyspnea by Modified-Borg Score | 1.2 ± 3.8 | 2.4 ± 2.0 |
Duration of antibiotics was collected from medical record. We have calculated the mean and the standard deviation for both groups.
| days | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care |
|---|---|---|
| Duration of Antibiotics | 8.8 ± 4.5 | 7.4 ± 4.3 |
Duration of fever was collected from medical record. We have calculated the mean and the standard deviation for both groups.
| days | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care |
|---|---|---|
| Duration of Fever | NA ± NA | 0.8 ± 1.0 |
Number of participants with need for oxygen supplement at the time of hospital discharge was collected from medical record for both groups.
| Participants | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care |
|---|---|---|
| Number of Participants With Need for Oxygen Supplement at Hospital Discharge | 0 | 0 |
Number of total hospital readmissions post-enrollment was obtained from medical record.
| Participants | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care |
|---|---|---|
| Reported 30-, 60-, and 90-day Readmission Rates | 0 | 0 |
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.
| Participants | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care |
|---|---|---|
| Number of Participants With Positive Sputum Culture | 1 | 3 |
Number of participants transferred to the intensive care unit post enrollment was obtained from medical record for both groups.
| Participants | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care |
|---|---|---|
| Number of Participants Transferred to the Intensive Care Unit (ICU) | 1 | 1 |
Collected over Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up to a week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OPEP Therapy Added to Standard Pneumonia Care | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Standard Pneumonia Care | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care | Total |
|---|---|---|---|
| Mean | 75.6 ± 20.0 | 78.2 ± 11.3 | 77 ± 15.1 |
| Sex: Female, Male(Participants) | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 2 | 2 | 4 |
| Ethnicity (NIH/OMB)(Participants) | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 4 | 6 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 3 | 3 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| BMI(kg/m^2) | OPEP Therapy Added to Standard Pneumonia Care | Standard Pneumonia Care | Total |
|---|---|---|---|
| Mean | 37.4 ± 0.8 | 24.7 ± 3.0 | 30.4 ± 7.0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Danbury Hospital