Clinical trial NCT04540510: OPEP Devices in Acute Inpatient Treatment of Pneumonia
Official title: Oscillatory Positive Expiratory Pressure Devices in Acute Inpatient Treatment of Pneumonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: Oscillatory positive expiratory pressure
Lead sponsor: Danbury Hospital
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients randomized to the OPEP therapy added to standard pneumonia care OR standard pneumonia care..
Primary purpose: TREATMENT

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: duration of hospital stay, an expected average of 4 days
Secondary outcomes:
measure: Reported Dyspnea by Modified-Borg Score
timeFrame: duration of hospital stay, an expected average of 4 days
measure: Duration of Antibiotics
timeFrame: duration of hospital stay, an expected average of 4 days
measure: Duration of Fever
timeFrame: duration of hospital stay, an expected average of 4 days
measure: Number of Participants With Need for Oxygen Supplement at Hospital Discharge
timeFrame: duration of hospital stay, an expected average of 4 days
measure: Reported 30-, 60-, and 90-day Readmission Rates
timeFrame: 90 day after the hospital discharge
measure: Number of Participants With Positive Sputum Culture
timeFrame: duration of hospital stay, an expected average of 4 days
measure: Number of Participants Transferred to the Intensive Care Unit (ICU)
timeFrame: duration of hospital stay, an expected average of 4 days
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
Study officials:
affiliation: Nuvance Health
name: Amy Ahasic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: De Alba I, Amin A. Pneumonia readmissions: risk factors and implications. Ochsner J. 2014 Winter;14(4):649-54.