Community Acquired Pneumonia in Older Adults
- Conditions
- PneumoniaAspiration Pneumonia
- Interventions
- Diagnostic Test: Videofluoroscopic Swallowing StudyDiagnostic Test: Nuclear medicine pulmonary aspiration studyDiagnostic Test: TOR-BSST and 3 oz Water SwallowDiagnostic Test: Sputum CultureDiagnostic Test: MeMed BV®Diagnostic Test: Lung UltrasoundDiagnostic Test: Respiratory Function Tests
- Registration Number
- NCT04709978
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 60 years of age or older
- 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
- Prisoner
- Non-English speaking
- Respiratory symptoms for 7 days or more
Phone Recruitment
Inclusion Criteria:
- 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:
- Prisoner
- Non-English speaking
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pneumonia Sputum Culture 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. Pneumonia Videofluoroscopic Swallowing Study 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. Pneumonia TOR-BSST and 3 oz Water Swallow 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. Pneumonia Lung Ultrasound 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. Pneumonia Nuclear medicine pulmonary aspiration study 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. Pneumonia MeMed BV® 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. Pneumonia Respiratory Function Tests 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Aspiration up to 6 months on study As defined by VFSS and radionuclide salivagram imaging studies.
- Secondary Outcome Measures
Name Time Method Lung Ultrasound Findings for ED participants at ED visit, baseline 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.
Peak Expiratory Flow (PEF) Any point during follow up within 6 months of index visit A handheld digital peak cough flow meter will be used to assess PEF to quantify cough function. This test will take approximately 3 minutes.
Forced Expiratory Volume (FEV1) Any point during follow up within 6 months of index visit 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.
Salivary pH Any point during follow up within 6 months of index visit Salivary pH will be measured using a digital pH meter.
Recurrent pneumonia Any point during follow up within 6 months of index visit As assessed on medical chart review
Percent Viral vs. Bacterial Infection for ED participants at ED visit, baseline MeMed BV® test results for participants recruited in the ED.
Salivary extensional viscosity Any point during follow up within 6 months of index visit Extensional viscosity will be determined using an extensional rheometer (Thermo-Fisher CaBER) and will be recorded 3 times per sample.
Salivary Substance P Concentration Any point during follow up within 6 months of index visit Substance P is a salivary protein
Patient Reported Swallowing Function as measured by physical symptoms on SWAL-QOL at Point of Care visit, up to 6 months 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.
Respiratory Pressure Any point during follow up within 6 months of index visit Maximum expiratory pressure and maximum inspiratory pressure will be measured using a handheld digital manometer. This test will take approximately 5 minutes.
Trial Locations
- Locations (1)
University of Wisconsin
🇺🇸Madison, Wisconsin, United States