Community Acquired Pneumonia in Older Adults

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Recruiting
CT.gov ID
NCT04709978
Collaborator
(none)
62
1
33.2
1.9

Study Details

Study Description

Brief Summary

This study will utilize diagnostic imaging to estimate the prevalence of aspiration in older adults with suspected community-acquired bacterial pneumonia (CABP). 150 participants over the age of 60 diagnosed with pneumonia in the University of Wisconsin (UW) Emergency Department will be recruited into this study.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Videofluoroscopic Swallowing Study
  • Diagnostic Test: Nuclear medicine pulmonary aspiration study
  • Diagnostic Test: TOR-BSST and 3 oz Water Swallow
  • Diagnostic Test: Sputum Culture

Detailed Description

Pneumonia is the most common infectious cause of mortality in older adults. Standard practice for older adults with pneumonia involves hospitalization and antibiotics. However, recent studies suggest that a significant portion of suspected community-acquired bacterial pneumonia (CABP) cases may actually be due to distinct, dysphagia-related aspiration syndromes (e.g. aspiration pneumonia, pneumonitis).

The proposed study will utilize diagnostic imaging to generate a prevalence estimate for aspiration in older adults diagnosed with pneumonia. The following aim will be completed:

Determine the prevalence of aspiration among older adults with pneumonia and rates of recurrent pneumonia in this population.

Study Design

Study Type:
Observational
Anticipated Enrollment :
62 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Redefining Community Acquired Pneumonia in Older Adults: The Role and Impact of Aspiration
Actual Study Start Date :
Feb 24, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Pneumonia

Participants will be over the age of 65 and diagnosed with pneumonia in the UW Emergency Department.

Diagnostic Test: Videofluoroscopic Swallowing Study
Participants swallow different barium containing liquid and food boluses types that are captured on fluoroscopic imaging in real time.

Diagnostic Test: Nuclear medicine pulmonary aspiration study
Participants will be administered radiotracer (Tc-99m-Sulfur Colloid) orally and static images of the chest will then be obtained at specified intervals over the next 2 hours to determine location of the radiotracer.

Diagnostic Test: TOR-BSST and 3 oz Water Swallow
The research specialist will conduct ten 1 tsp water swallows, one cup sip of water and a 3 ounce water swallow test with the patient. After each swallow, the participant is asked to say "ah" so that their voice quality can be assessed.
Other Names:
  • bedside dysphagia screening; 3 ounce water swallow test
  • Diagnostic Test: Sputum Culture
    Patients will have sputum collected during stay

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Aspiration [Any point during follow up within 6 months of index visit]

      As defined by imaging studies.

    Secondary Outcome Measures

    1. Recurrent pneumonia [Any point during follow up within 6 months of index visit]

      As assessed on medical chart review

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 60 years of age or older

    • Patient has pneumonia or is being treated for pneumonia as defined by abnormal chest imaging or receiving antibiotics for a chest infection or the provider thinks the patient has pneumonia or is planning to treat the patient for pneumonia.

    • Patient is clinically stable and able to safely drink water, per the emergency department provider

    • Ability to provide consent or the presence of a legally authorized representative (LAR) who can consent on behalf of the patient

    Exclusion Criteria:
    • Prisoner

    • Non-English speaking

    • Allergy to barium

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Wisconsin Madison Wisconsin United States 53705

    Sponsors and Collaborators

    • University of Wisconsin, Madison

    Investigators

    • Principal Investigator: Michael Pulia, MD, MS, University of Wisconsin, Madison

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT04709978
    Other Study ID Numbers:
    • 2020-1121
    • Protocol Version 0.11
    • A534100
    • SMPH/EMERG MED
    • A534255
    First Posted:
    Jan 14, 2021
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 4, 2022