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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 11/3/22 | Other Identifier | UW Madison | |
| A534100 | Other Identifier | UW Madison | |
| SMPH/EMERG MED | Other Identifier | UW Madison | |
| A534255 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Gordon and Betty Moore Foundation | OTHER |
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This study will utilize diagnostic imaging and salivary biomarkers 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 will be recruited into this study. 62 of these participants will be enrolled in a supplemental study.
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 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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Videofluoroscopic Swallowing Study | Diagnostic Test | Participants enrolled in supplemental study will swallow different barium containing liquid and food boluses types that are captured on fluoroscopic imaging in real time. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Aspiration | As defined by VFSS and radionuclide salivagram imaging studies. | up to 6 months on study |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary extensional viscosity | Extensional viscosity will be determined using an extensional rheometer (Thermo-Fisher CaBER) and will be recorded 3 times per sample. | Any point during follow up within 6 months of index visit |
| Salivary Substance P Concentration |
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Emergency Department (ED) Recruitment
Inclusion Criteria:
Exclusion Criteria:
Phone Recruitment
Inclusion Criteria:
Exclusion Criteria:
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Patients recruited from the UW Emergency Department and via phone, 60 years of age or older diagnosed with or treated for pneumonia in the past 6 months.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Pulia, MD, MS | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D011015 | Pneumonia, Aspiration |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Saliva and mouth swabs, blood samples
| Nuclear medicine pulmonary aspiration study | Diagnostic Test | 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. |
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| TOR-BSST and 3 oz Water Swallow | Diagnostic Test | 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. |
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| Sputum Culture | Diagnostic Test | Patients will have sputum collected during stay (ED participants only) |
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| MeMed BV® | Diagnostic Test | A blood test to help determine if the infection is viral or bacterial (ED participants only) |
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| Lung Ultrasound | Diagnostic Test | To image the lungs (ED participants only) |
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| Respiratory Function Tests | Diagnostic Test | To measure respiratory pressures. |
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Substance P is a salivary protein |
| Any point during follow up within 6 months of index visit |
| Salivary pH | Salivary pH will be measured using a digital pH meter. | Any point during follow up within 6 months of index visit |
| Recurrent pneumonia | As assessed on medical chart review | Any point during follow up within 6 months of index visit |
| Lung Ultrasound Findings for ED participants | Lung ultrasound exams will be compared between older adults with aspiration related pneumonia mimics and those with infectious pneumonia. Interpretation of ultrasound images will be performed by two ultrasound fellowship trained EM faculty, blinded to any clinical information. Each lung ultrasound view captured will be reviewed and interpreted descriptively. Lung ultrasound findings will be described with the following features: crisp or irregular pleural line, A line artifacts, isolated Z line artifacts, static air bronchograms, dynamic air bronchograms, tissue-like consolidation without bronchograms, coalescent B lines (presence and how many per interspace), discrete B lines (presence and how many per interspace), subpleural hypoechoic consolidation, and pleural effusion. | at ED visit, baseline |
| Patient Reported Swallowing Function as measured by physical symptoms on SWAL-QOL | All participants will complete self report surveys at their first study visit. The physical symptoms question on the SWAL-QOL asks the participant to identify how often they experienced specific symptoms in the past month, from 1 (almost always) to 5 (never). The total score is transposed to 0-100 with higher scores indicating better swallowing function. | at Point of Care visit, up to 6 months |
| Percent Viral vs. Bacterial Infection for ED participants | MeMed BV® test results for participants recruited in the ED. | at ED visit, baseline |
| Respiratory Pressure | Maximum expiratory pressure and maximum inspiratory pressure will be measured using a handheld digital manometer. This test will take approximately 5 minutes. | Any point during follow up within 6 months of index visit |
| Peak Expiratory Flow (PEF) | A handheld digital peak cough flow meter will be used to assess PEF to quantify cough function. This test will take approximately 3 minutes. | Any point during follow up within 6 months of index visit |
| Forced Expiratory Volume (FEV1) | A handheld digital peak cough flow meter will be used to assess forced expiratory volume (FEV1) to quantify cough function. This test will take approximately 3 minutes. | Any point during follow up within 6 months of index visit |