Study Results
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View full resultsBasic Information
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TERMINATED
NA
11 participants
INTERVENTIONAL
2019-08-13
2021-02-18
Brief Summary
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Approximately 200 subjects are expected to participate in this study.
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
OPEP therapy
Oscillatory Positive Expiratory Pressure therapy
Standard care
Standard pneumonia care
Standard pneumonia care
The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Standard care
Standard pneumonia care
Interventions
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OPEP therapy
Oscillatory Positive Expiratory Pressure therapy
Standard care
Standard pneumonia care
Eligibility Criteria
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Inclusion Criteria
* Any new chest radiographic infiltrate consistent with pneumonia
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Danbury Hospital
OTHER
Responsible Party
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Principal Investigators
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Amy Ahasic, MD
Role: PRINCIPAL_INVESTIGATOR
Nuvance Health
Locations
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Norwalk Hospital
Norwalk, Connecticut, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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18-1104
Identifier Type: -
Identifier Source: org_study_id
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