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OPEP Devices in Acute Inpatient Treatment of Pneumonia

Oscillatory Positive Expiratory Pressure Devices in Acute Inpatient Treatment of Pneumonia

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04540510
Acronym
OPEP
Enrollment
11
Registered
2020-09-07
Start date
2019-08-13
Completion date
2021-02-18
Last updated
2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

Keywords

Oscillatory positive expiratory pressure

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)

Interventions

DEVICEOPEP therapy

Oscillatory Positive Expiratory Pressure therapy

OTHERStandard care

Standard pneumonia care

Sponsors

Danbury Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Patients randomized to the OPEP therapy added to standard pneumonia care OR standard pneumonia care..

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Length of Hospital Stayduration of hospital stay, an expected average of 4 daysNumber 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

MeasureTime frameDescription
Duration of Antibioticsduration of hospital stay, an expected average of 4 daysDuration of antibiotics was collected from medical record. We have calculated the mean and the standard deviation for both groups.
Duration of Feverduration of hospital stay, an expected average of 4 daysDuration of fever was collected from medical record. We have calculated the mean and the standard deviation for both groups.
Number of Participants With Need for Oxygen Supplement at Hospital Dischargeduration of hospital stay, an expected average of 4 daysNumber of participants with need for oxygen supplement at the time of hospital discharge was collected from medical record for both groups.
Reported Dyspnea by Modified-Borg Scoreduration of hospital stay, an expected average of 4 daysDyspnea 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.
Number of Participants With Positive Sputum Cultureduration of hospital stay, an expected average of 4 daysData 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.
Number of Participants Transferred to the Intensive Care Unit (ICU)duration of hospital stay, an expected average of 4 daysNumber of participants transferred to the intensive care unit post enrollment was obtained from medical record for both groups.
Reported 30-, 60-, and 90-day Readmission Rates90 day after the hospital dischargeNumber of total hospital readmissions post-enrollment was obtained from medical record.

Countries

United States

Participant flow

Participants by arm

ArmCount
OPEP Therapy Added to Standard Pneumonia 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.
5
Standard Pneumonia Care
The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
6
Total11

Baseline characteristics

CharacteristicOPEP Therapy Added to Standard Pneumonia CareStandard Pneumonia CareTotal
Age, Continuous75.6 years
STANDARD_DEVIATION 20
78.2 years
STANDARD_DEVIATION 11.3
77 years
STANDARD_DEVIATION 15.1
BMI37.4 kg/m^2
STANDARD_DEVIATION 0.8
24.7 kg/m^2
STANDARD_DEVIATION 3
30.4 kg/m^2
STANDARD_DEVIATION 7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants6 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
3 Participants3 Participants6 Participants
Sex: Female, Male
Female
3 Participants4 Participants7 Participants
Sex: Female, Male
Male
2 Participants2 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 50 / 6
other
Total, other adverse events
0 / 50 / 6
serious
Total, serious adverse events
0 / 50 / 6

Outcome results

Primary

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

Population: Although 6 subjects were recruited in the control group, however, we are missing this variable in data collection sheet for one subject in the control group. Therefore, we have only evaluated 5 subjects in the control group for this analysis.

ArmMeasureValue (MEAN)Dispersion
OPEP Therapy Added to Standard Pneumonia CareLength of Hospital Stay1.2 daysStandard Deviation 0.9
Standard Pneumonia CareLength of Hospital Stay4.0 daysStandard Deviation 1.2
Secondary

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

Population: Although 6 subjects were recruited in the control group, however, we are missing this variable in data collection sheet for one subject in the control group. Therefore, we have only evaluated 5 subjects in the control group for this analysis.

ArmMeasureValue (MEAN)Dispersion
OPEP Therapy Added to Standard Pneumonia CareDuration of Antibiotics8.8 daysStandard Deviation 4.5
Standard Pneumonia CareDuration of Antibiotics7.4 daysStandard Deviation 4.3
Secondary

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

ArmMeasureValue (MEAN)Dispersion
OPEP Therapy Added to Standard Pneumonia CareDuration of FeverNA days
Standard Pneumonia CareDuration of Fever0.8 daysStandard Deviation 1
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OPEP Therapy Added to Standard Pneumonia CareNumber of Participants Transferred to the Intensive Care Unit (ICU)1 Participants
Standard Pneumonia CareNumber of Participants Transferred to the Intensive Care Unit (ICU)1 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OPEP Therapy Added to Standard Pneumonia CareNumber of Participants With Need for Oxygen Supplement at Hospital Discharge0 Participants
Standard Pneumonia CareNumber of Participants With Need for Oxygen Supplement at Hospital Discharge0 Participants
Secondary

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

Population: Although 6 subjects were recruited in the control group, however, we are missing this variable in data collection sheet for one subject in the control group. Therefore, we have only evaluated 5 subjects in the control group for this analysis.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OPEP Therapy Added to Standard Pneumonia CareNumber of Participants With Positive Sputum Culture1 Participants
Standard Pneumonia CareNumber of Participants With Positive Sputum Culture3 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OPEP Therapy Added to Standard Pneumonia CareReported 30-, 60-, and 90-day Readmission Rates0 Participants
Standard Pneumonia CareReported 30-, 60-, and 90-day Readmission Rates0 Participants
Secondary

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

ArmMeasureValue (MEAN)Dispersion
OPEP Therapy Added to Standard Pneumonia CareReported Dyspnea by Modified-Borg Score1.2 score on scaleStandard Deviation 3.8
Standard Pneumonia CareReported Dyspnea by Modified-Borg Score2.4 score on scaleStandard Deviation 2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026