OPEP Devices in Acute Inpatient Treatment of Pneumonia

NCT04540510 | Terminated Results FDA Device

• 1 other identifier: 18-1104
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Community-acquired Pneumonia

Keywords

Oscillatory positive expiratory pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Reported Dyspnea by Modified-Borg Score

  duration of hospital stay, an expected average of 4 days

• Duration of Antibiotics

  duration of hospital stay, an expected average of 4 days

• Duration of Fever

  duration of hospital stay, an expected average of 4 days

• Number of Participants With Need for Oxygen Supplement at Hospital Discharge

  duration of hospital stay, an expected average of 4 days

• Reported 30-, 60-, and 90-day Readmission Rates

  90 day after the hospital discharge

Study Arms (2)

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.

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.

Other: Standard care

Interventions

OPEP therapy DEVICE

Oscillatory Positive Expiratory Pressure therapy

OPEP therapy added to standard pneumonia care

Standard care OTHER

Standard pneumonia care

OPEP therapy added to standard pneumonia care; Standard pneumonia care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical symptoms suggesting pneumonia (eg. cough, fever, pleuritic chest pain, sputum production, dyspnea)
• Any new chest radiographic infiltrate consistent with pneumonia

You may not qualify if:

• 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)

Sponsors & Collaborators

• Danbury Hospital: lead

Study Sites (1)

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Related Publications (9)

• 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.

  PMID: 23450568 BACKGROUND

• 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.

  PMID: 24717858 BACKGROUND

• 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.

  PMID: 355879 BACKGROUND

• 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.

  PMID: 2106412 BACKGROUND

• 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.

  PMID: 9600479 BACKGROUND

• 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.

  PMID: 23605251 BACKGROUND

• 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.

  PMID: 20203464 BACKGROUND

• 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.

  PMID: 29089755 BACKGROUND

• De Alba I, Amin A. Pneumonia readmissions: risk factors and implications. Ochsner J. 2014 Winter;14(4):649-54.

  PMID: 25598730 BACKGROUND

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Joann Petrini
• Organization: Nuvance Health (formerly Western Connecticut Health Network)

Joann.Petrini@wchn.org

203-739-6882

Study Officials

• Amy Ahasic, MD

  Nuvance Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients randomized to the OPEP therapy added to standard pneumonia care OR standard pneumonia care..

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 7, 2020
• Study Start: August 13, 2019
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: September 24, 2021
• Results First Posted: September 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)