OPEP Devices in Acute Inpatient Treatment of Pneumonia

• Sponsor: Danbury Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04540510
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.2
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Pneumonia	Device: OPEP therapy; Other: Standard care	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients randomized to the OPEP therapy added to standard pneumonia care OR standard pneumonia care..Patients randomized to the OPEP therapy added to standard pneumonia care OR standard pneumonia care..
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Oscillatory Positive Expiratory Pressure Devices in Acute Inpatient Treatment of Pneumonia
• Actual Study Start Date: Aug 13, 2019
• Actual Primary Completion Date: Feb 18, 2021
• Actual Study Completion Date: Feb 18, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Length of Hospital Stay [duration of hospital stay, an expected average of 4 days]

   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.

Secondary Outcome Measures

1. Reported Dyspnea by Modified-Borg Score [duration of hospital stay, an expected average of 4 days]

   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.

2. Duration of Antibiotics [duration of hospital stay, an expected average of 4 days]

   Duration of antibiotics was collected from medical record. We have calculated the mean and the standard deviation for both groups.

3. Duration of Fever [duration of hospital stay, an expected average of 4 days]

   Duration of fever was collected from medical record. We have calculated the mean and the standard deviation for both groups.

4. Number of Participants With Need for Oxygen Supplement at Hospital Discharge [duration of hospital stay, an expected average of 4 days]

   Number of participants with need for oxygen supplement at the time of hospital discharge was collected from medical record for both groups.

5. Reported 30-, 60-, and 90-day Readmission Rates [90 day after the hospital discharge]

   Number of total hospital readmissions post-enrollment was obtained from medical record.

6. Number of Participants With Positive Sputum Culture [duration of hospital stay, an expected average of 4 days]

   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.

7. Number of Participants Transferred to the Intensive Care Unit (ICU) [duration of hospital stay, an expected average of 4 days]

   Number of participants transferred to the intensive care unit post enrollment was obtained from medical record for both groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norwalk Hospital	Norwalk	Connecticut	United States	06856

Sponsors and Collaborators

• Danbury Hospital

Investigators

• Principal Investigator: Amy Ahasic, MD, Nuvance Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 4, 2019

More Information

Publications

• 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.
• De Alba I, Amin A. Pneumonia readmissions: risk factors and implications. Ochsner J. 2014 Winter;14(4):649-54. Review.
• 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. Review.
• 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.
• 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.
• 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.
• 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. pii: bcr2013202598. doi: 10.1136/bcr-2013-202598.
• 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.
• 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. Review.

• Responsible Party: Danbury Hospital
• ClinicalTrials.gov Identifier: NCT04540510
• Other Study ID Numbers: 18-1104
• First Posted: Sep 7, 2020
• Last Update Posted: Sep 24, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Danbury Hospital: Oscillatory positive expiratory pressure
• Additional relevant MeSH terms: Pneumonia

Study Results

Participant Flow

Arm/Group Title	OPEP Therapy Added to Standard Pneumonia Care	Standard Pneumonia Care
Arm/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.	The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Period Title: Overall Study
STARTED	5	6
COMPLETED	5	6
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	OPEP Therapy Added to Standard Pneumonia Care	Standard Pneumonia Care	Total
Arm/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.	The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.	Total of all reporting groups
Overall Participants	5	6	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.6 (20.0)	78.2 (11.3)	77 (15.1)
Sex: Female, Male (Count of Participants)
Female	3 60%	4 66.7%	7 63.6%
Male	2 40%	2 33.3%	4 36.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 20%	0 0%	1 9.1%
Not Hispanic or Latino	4 80%	6 100%	10 90.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 16.7%	1 9.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 20%	2 33.3%	3 27.3%
White	3 60%	3 50%	6 54.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 20%	0 0%	1 9.1%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	37.4 (0.8)	24.7 (3.0)	30.4 (7.0)

Outcome Measures

1. Primary Outcome

Title	Length of Hospital Stay
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	OPEP Therapy Added to Standard Pneumonia Care	Standard Pneumonia Care
Arm/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.	The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Measure Participants	5	5
Mean (Standard Deviation) [days]	1.2 (0.9)	4.0 (1.2)

2. Secondary Outcome

Title	Reported Dyspnea by Modified-Borg Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OPEP Therapy Added to Standard Pneumonia Care	Standard Pneumonia Care
Arm/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.	The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Measure Participants	5	6
Mean (Standard Deviation) [score on scale]	1.2 (3.8)	2.4 (2.0)

3. Secondary Outcome

Title	Duration of Antibiotics
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	OPEP Therapy Added to Standard Pneumonia Care	Standard Pneumonia Care
Arm/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.	The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Measure Participants	5	5
Mean (Standard Deviation) [days]	8.8 (4.5)	7.4 (4.3)

4. Secondary Outcome

Title	Duration of Fever
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OPEP Therapy Added to Standard Pneumonia Care	Standard Pneumonia Care
Arm/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.	The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Measure Participants	5	6
Mean (Standard Deviation) [days]	NA (NA)	0.8 (1.0)

5. Secondary Outcome

Title	Number of Participants With Need for Oxygen Supplement at Hospital Discharge
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OPEP Therapy Added to Standard Pneumonia Care	Standard Pneumonia Care
Arm/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.	The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Measure Participants	5	6
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

Title	Reported 30-, 60-, and 90-day Readmission Rates
Description	Number of total hospital readmissions post-enrollment was obtained from medical record.
Time Frame	90 day after the hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OPEP Therapy Added to Standard Pneumonia Care	Standard Pneumonia Care
Arm/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.	The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Measure Participants	5	6
Count of Participants [Participants]	0 0%	0 0%

7. Secondary Outcome

Title	Number of Participants With Positive Sputum Culture
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	OPEP Therapy Added to Standard Pneumonia Care	Standard Pneumonia Care
Arm/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.	The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Measure Participants	5	5
Count of Participants [Participants]	1 20%	3 50%

8. Secondary Outcome

Title	Number of Participants Transferred to the Intensive Care Unit (ICU)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OPEP Therapy Added to Standard Pneumonia Care	Standard Pneumonia Care
Arm/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.	The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Measure Participants	5	6
Count of Participants [Participants]	1 20%	1 16.7%

Adverse Events

Time Frame	Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up to a week
Arm/Group Title	OPEP Therapy Added to Standard Pneumonia Care		Standard Pneumonia Care
Arm/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.		The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
All Cause Mortality
	OPEP Therapy Added to Standard Pneumonia Care		Standard Pneumonia Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/6 (0%)
Serious Adverse Events
	OPEP Therapy Added to Standard Pneumonia Care		Standard Pneumonia Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	OPEP Therapy Added to Standard Pneumonia Care		Standard Pneumonia Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.