Community-acquired PneumoniaOPEPNCT04540510
OPEP Devices in Acute Inpatient Treatment of Pneumonia
A study testing OPEP therapy in people with Community-acquired Pneumonia, run by Danbury Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- OPEP therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2019to 18 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical symptoms suggesting pneumonia (eg. cough, fever, pleuritic chest pain, sputum production, dyspnea)
- Any new chest radiographic infiltrate consistent with pneumonia
Who cannot join
- 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)
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Reduction in hospital length of stay
Secondary outcomes
- Reduction in dyspnea by modified-Borg score
- Reduction in duration of antibiotics
- Reduction in duration of fever
- Reduction in need for oxygen at hospital discharge
- Reduction in 30-, 60-, and 90-day readmission rates
- Diagnosis of organism by sputum
- Transfer to the intensive care unit (ICU)
- Conditions
- Community-acquired Pneumonia
- Being tested
- OPEP therapy, Standard care
- Keywords
- Oscillatory positive expiratory pressure
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPEP therapyDevice
Oscillatory Positive Expiratory Pressure therapy
Standard careOther
Standard pneumonia care
| Study group | Role | What they receive |
|---|---|---|
| OPEP therapy added to standard pneumonia care | Active comparator | 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. Receives: Device: OPEP therapy; Other: Standard care |
| Standard pneumonia care | Active comparator | The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: duration of hospital stay, an expected average of 4 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: duration of hospital stay, an expected average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start13 Aug 2019
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Why it stopped: due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomized to the OPEP therapy added to standard pneumonia care OR standard pneumonia care..
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danbury Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Ahasic, MD, Principal investigator, Nuvance Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540510
- Sponsor's protocol ID
- 18-1104
- Acronym
- OPEP
- Status last verified
- Aug 2021
- First submitted
- 28 Aug 2020
- Last updated
- 24 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 23450568Narula 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.
PubMed 24717858Graham 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.
PubMed 355879Christensen 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.
PubMed 2106412Halm 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.
PubMed 9600479Sato 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.
PubMed 23605251File 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.
PubMed 20203464Khoudigian-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.
PubMed 29089755De Alba I, Amin A. Pneumonia readmissions: risk factors and implications. Ochsner J. 2014 Winter;14(4):649-54.
PubMed 25598730
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oscillatory Positive Expiratory Pressure Devices in Acute Inpatient Treatment of Pneumonia
- ClinicalTrials.gov ID
- NCT04540510
- Acronym / sponsor ID
- OPEP / 18-1104
- Conditions
- Community-acquired Pneumonia
- Keywords
- Oscillatory positive expiratory pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to COVID-19
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Danbury HospitalUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Posted 24 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Reduction in hospital length of stay
Secondary outcomes
- Reduction in dyspnea by modified-Borg score
- Reduction in duration of antibiotics
- Reduction in duration of fever
- Reduction in need for oxygen at hospital discharge
- Reduction in 30-, 60-, and 90-day readmission rates
- Diagnosis of organism by sputum
- Transfer to the intensive care unit (ICU)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients randomized to the OPEP therapy added to standard pneumonia care OR standard pneumonia care..
| Arm | Type | Receives |
|---|---|---|
| OPEP therapy added to standard pneumonia care | Active comparator | Device: OPEP therapy, Other: Standard careThe 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. |
| Standard pneumonia care | Active comparator | Other: Standard careThe control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical symptoms suggesting pneumonia (eg. cough, fever, pleuritic chest pain, sputum production, dyspnea)
- Any new chest radiographic infiltrate consistent with pneumonia
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPEP therapyOscillatory Positive Expiratory Pressure therapy | Device | OPEP therapy added to standard pneumonia care |
| Standard careStandard pneumonia care | Other | OPEP therapy added to standard pneumonia care, Standard pneumonia care |
Primary outcome
Length of Hospital Stay
Time frame: 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.
7 secondary outcomes
Reported Dyspnea by Modified-Borg Score
Time frame: duration of hospital stay, an expected average of 4 days
Duration of Antibiotics
Time frame: duration of hospital stay, an expected average of 4 days
Duration of Fever
Time frame: duration of hospital stay, an expected average of 4 days
Number of Participants With Need for Oxygen Supplement at Hospital Discharge
Time frame: duration of hospital stay, an expected average of 4 days
Reported 30-, 60-, and 90-day Readmission Rates
Time frame: 90 day after the hospital discharge
Number of Participants With Positive Sputum Culture
Time frame: duration of hospital stay, an expected average of 4 days
Number of Participants Transferred to the Intensive Care Unit (ICU)
Time frame: duration of hospital stay, an expected average of 4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23450568Yang 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.
- Background: PubMed 24717858Narula 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.
- Background: PubMed 355879Graham 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.
- Background: PubMed 2106412Christensen 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.
- Background: PubMed 9600479Halm 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.
- Background: PubMed 23605251Sato 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.
- Background: PubMed 20203464File 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.
- Background: PubMed 29089755Khoudigian-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.
- Background: PubMed 25598730De Alba I, Amin A. Pneumonia readmissions: risk factors and implications. Ochsner J. 2014 Winter;14(4):649-54.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Ahasic, MD principal investigator
Nuvance Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPEP therapy in people with Community-acquired Pneumonia, run by Danbury Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: duration of hospital stay, an expected average of 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04540510, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.