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OPEP Devices in Acute Inpatient Treatment of Pneumonia
NA trial testing OPEP therapy in Community-acquired Pneumonia in 11 participants. Terminated before completion.
| Lead sponsor | Danbury Hospital |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 13 August 2019 |
| Primary completion | 18 February 2021 |
| Estimated completion | 18 February 2021 |
| Sites | 1 location across United States |
Danbury Hospital
18 and older, any sex, with Community-acquired Pneumonia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| OPEP Therapy Added to Standard Pneumonia Care | 1.2 | ± 0.9 |
| Standard Pneumonia Care | 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.
| Group | Value | 95% CI |
|---|---|---|
| OPEP Therapy Added to Standard Pneumonia Care | 1.2 | ± 3.8 |
| Standard Pneumonia Care | 2.4 | ± 2.0 |
Duration of antibiotics was collected from medical record. We have calculated the mean and the standard deviation for both groups.
| Group | Value | 95% CI |
|---|---|---|
| OPEP Therapy Added to Standard Pneumonia Care | 8.8 | ± 4.5 |
| Standard Pneumonia Care | 7.4 | ± 4.3 |
Duration of fever was collected from medical record. We have calculated the mean and the standard deviation for both groups.
| Group | Value | 95% CI |
|---|---|---|
| OPEP Therapy Added to Standard Pneumonia Care | NA | ± NA |
| Standard Pneumonia Care | 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.
| Group | Value | 95% CI |
|---|---|---|
| OPEP Therapy Added to Standard Pneumonia Care | 0 | |
| Standard Pneumonia Care | 0 |
Number of total hospital readmissions post-enrollment was obtained from medical record.
| Group | Value | 95% CI |
|---|---|---|
| OPEP Therapy Added to Standard Pneumonia Care | 0 | |
| Standard Pneumonia Care | 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.
| Group | Value | 95% CI |
|---|---|---|
| OPEP Therapy Added to Standard Pneumonia Care | 1 | |
| Standard Pneumonia Care | 3 |
Number of participants transferred to the intensive care unit post enrollment was obtained from medical record for both groups.
| Group | Value | 95% CI |
|---|---|---|
| OPEP Therapy Added to Standard Pneumonia Care | 1 | |
| Standard Pneumonia Care | 1 |
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.
No peer-reviewed publications indexed yet for this trial.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing