OPEP Devices in Acute Inpatient Treatment of Pneumonia

Danbury Hospital

Status: Terminated

Conditions: Community-acquired Pneumonia

Treatments: Device: OPEP therapy; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04540510

18-1104

Details and patient eligibility

About

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.

Full 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)

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

11 participants in 2 patient groups

OPEP therapy added to standard pneumonia care

Active Comparator group

Description:

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.

Treatment:

Other: Standard care

Device: OPEP therapy

Standard pneumonia care

Active Comparator group

Description:

The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.

Treatment:

Other: Standard care