Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2021-02-24
2023-07-02
Brief Summary
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Detailed Description
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The main study will will assess whether salivary biomarkers (viscoelasticity, substance P) and swallowing function tests can be used to help differentiate CABP from aspiration-related syndromes. The following aims will be completed:
* Aim 1: Compare salivary properties and health outcomes among older adults with aspiration related pneumonia mimics and those with infectious pneumonia
* Aim 2: Compare appearance of lung ultrasound findings among older adults with aspiration related pneumonia mimics and those with infectious pneumonia.
* Aim 3: Describe dysphagia screening results, patient reported swallowing function, salivary properties, oral/nasopharyngeal microbiome profiles, in older adults with pneumonia presenting to the ED.
* Aim 4: Assess the potential impact of the MeMed BV® test's result on patient management decision making, including antibiotic prescribing and disposition.
A supplemental study will be the first to utilize diagnostic imaging (videofluoroscopic evaluation of swallowing and radionuclide salivagram) to estimate the prevalence of aspiration in older adults with suspected CABP.
* Aim 1: Determine the prevalence of dysphagia-related aspiration among older adults with pneumonia.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pneumonia
Participants will be over the age of 60 and diagnosed with pneumonia in the UW Emergency Department or treated for pneumonia in the past 6 months.
Videofluoroscopic Swallowing Study
Participants enrolled in supplemental study will swallow different barium containing liquid and food boluses types that are captured on fluoroscopic imaging in real time.
Nuclear medicine pulmonary aspiration study
Participants enrolled in supplemental study 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.
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.
Sputum Culture
Patients will have sputum collected during stay (ED participants only)
MeMed BV®
A blood test to help determine if the infection is viral or bacterial (ED participants only)
Lung Ultrasound
To image the lungs (ED participants only)
Respiratory Function Tests
To measure respiratory pressures.
Interventions
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Videofluoroscopic Swallowing Study
Participants enrolled in supplemental study will swallow different barium containing liquid and food boluses types that are captured on fluoroscopic imaging in real time.
Nuclear medicine pulmonary aspiration study
Participants enrolled in supplemental study 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.
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.
Sputum Culture
Patients will have sputum collected during stay (ED participants only)
MeMed BV®
A blood test to help determine if the infection is viral or bacterial (ED participants only)
Lung Ultrasound
To image the lungs (ED participants only)
Respiratory Function Tests
To measure respiratory pressures.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has clinical criteria for 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
* 60 years of age and older
* Patient was diagnosed with or treated for pneumonia at UW Health in the past 6 months
* Ability to provide consent or the presence of a legally authorized representative (LAR) who can consent on behalf of the patient
Exclusion Criteria
* Non-English speaking
* Respiratory symptoms for 7 days or more
Phone Recruitment
* Prisoner
* Non-English speaking
60 Years
ALL
No
Sponsors
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Gordon and Betty Moore Foundation
OTHER
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Michael Pulia, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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Protocol Version 11/3/22
Identifier Type: OTHER
Identifier Source: secondary_id
A534100
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/EMERG MED
Identifier Type: OTHER
Identifier Source: secondary_id
A534255
Identifier Type: OTHER
Identifier Source: secondary_id
2020-1121
Identifier Type: -
Identifier Source: org_study_id
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