OPEP Devices in Acute Inpatient Treatment of Pneumonia (OPEP)

Oscillatory Positive Expiratory Pressure Devices in Acute Inpatient Treatment of Pneumonia

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.

Study Overview

• Status: Terminated
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Device: OPEP therapy; Other: Standard care

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)

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Norwalk, Connecticut, United States, 06856
      • Norwalk Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: OPEP therapy; Oscillatory Positive Expiratory Pressure therapy; Other: Standard care; Standard pneumonia care
Active Comparator: Standard pneumonia 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; Standard pneumonia care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	duration of hospital stay, an expected average of 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	duration of hospital stay, an expected average of 4 days

Collaborators and Investigators

• Sponsor: Danbury Hospital
• Investigators: Principal Investigator: Amy Ahasic, MD, Nuvance Health

Publications and helpful links

General Publications

• Yang M, Yan Y, Yin X, Wang BY, Wu T, Liu GJ, Dong BR. Chest physiotherapy for pneumonia in adults. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD006338. doi: 10.1002/14651858.CD006338.pub3.
• Narula D, Nangia V. Use of an oscillatory PEP device to enhance bronchial hygiene in a patient of post-H1NI pneumonia and acute respiratory distress syndrome with pneumothorax. BMJ Case Rep. 2014 Mar 7;2014:bcr2013202598. doi: 10.1136/bcr-2013-202598.
• Graham WG, Bradley DA. Efficacy of chest physiotherapy and intermittent positive-pressure breathing in the resolution of pneumonia. N Engl J Med. 1978 Sep 21;299(12):624-7. doi: 10.1056/NEJM197809212991203.
• Christensen EF, Nedergaard T, Dahl R. Long-term treatment of chronic bronchitis with positive expiratory pressure mask and chest physiotherapy. Chest. 1990 Mar;97(3):645-50. doi: 10.1378/chest.97.3.645.
• Halm EA, Fine MJ, Marrie TJ, Coley CM, Kapoor WN, Obrosky DS, Singer DE. Time to clinical stability in patients hospitalized with community-acquired pneumonia: implications for practice guidelines. JAMA. 1998 May 13;279(18):1452-7. doi: 10.1001/jama.279.18.1452.
• Sato R, Gomez Rey G, Nelson S, Pinsky B. Community-acquired pneumonia episode costs by age and risk in commercially insured US adults aged >/=50 years. Appl Health Econ Health Policy. 2013 Jun;11(3):251-8. doi: 10.1007/s40258-013-0026-0.
• File TM Jr, Marrie TJ. Burden of community-acquired pneumonia in North American adults. Postgrad Med. 2010 Mar;122(2):130-41. doi: 10.3810/pgm.2010.03.2130.
• Khoudigian-Sinani S, Kowal S, Suggett JA, Coppolo DP. Cost-effectiveness of the Aerobika* oscillating positive expiratory pressure device in the management of COPD exacerbations. Int J Chron Obstruct Pulmon Dis. 2017 Oct 19;12:3065-3073. doi: 10.2147/COPD.S143334. eCollection 2017.
• De Alba I, Amin A. Pneumonia readmissions: risk factors and implications. Ochsner J. 2014 Winter;14(4):649-54.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2019
• Primary Completion (Actual): February 18, 2021
• Study Completion (Actual): February 18, 2021

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Oscillatory positive expiratory pressure
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: 18-1104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No