Aspiration Pneumonia in Adults: Patient Characteristics, Diagnosis, Treatment, and Outcomes (ASPEN)
Aspiration Pneumonia in Adults: A Retrospective Cohort Study of Patient Characteristics, Risk Factors, Diagnosis, Treatment, and Clinical Outcomes
Aspiration pneumonia is a lung infection that can occur when food, liquid, saliva, or material from the stomach enters the airways. It is an important health problem, particularly among older adults and people with swallowing difficulties, neurological conditions, frailty, or reduced functional ability. Diagnosis can be challenging, and patients may differ in their risk factors, investigations, treatment, and outcomes.
The ASPEN study (Aspiration Pneumonia Evaluation Network) is a retrospective observational study of adults aged 18 years or older who were hospitalized in Region Örebro County, Sweden, with a registered diagnosis of aspiration pneumonia between September 2024 and September 2026.
The researchers will review existing medical records and collect information using a structured data collection form. Information will include patients' age and other characteristics, living situation and functional status, underlying diseases, risk factors for aspiration, clinical findings, imaging, microbiological investigations, antibiotic treatment, other healthcare interventions, and outcomes.
The study will describe the characteristics of patients hospitalized with aspiration pneumonia, how the condition is investigated and treated in routine clinical practice, and how patients' hospital stays and subsequent outcomes develop. Outcomes of interest include clinical deterioration, length of hospital stay, discharge destination, readmission, a new documented episode of aspiration pneumonia, and death within 90 days, where information is available.
The study will also explore associations between patient characteristics, clinical features, investigations, treatment patterns, and outcomes. As this is an observational study based on existing medical records, it is not designed to establish whether a particular treatment causes better or worse outcomes.
The overall aim is to improve knowledge of aspiration pneumonia and provide a foundation for future research, with particular attention to older adults, functional ability, and healthcare needs.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Background
Aspiration pneumonia is a clinically important condition in adults, particularly in older people and individuals with dysphagia, neurological disease, frailty, reduced functional ability, and other comorbidities. The diagnosis may be difficult to establish because aspiration is not always witnessed and documentation varies between patients and clinical settings. Diagnostic investigations, microbiological sampling, and antibiotic treatment may also vary in routine clinical practice.
A systematic description of patient characteristics, aspiration-related risk factors, diagnostic approaches, treatment patterns, and clinical outcomes may help identify gaps in clinical documentation and areas for future research. This is particularly relevant to older adults, in whom an episode of pneumonia may be associated with functional decline, prolonged hospitalization, increased care needs, and recurrent healthcare contacts.
Study design and setting
ASPEN (Aspiration Pneumonia Evaluation Network) is a retrospective, observational cohort study conducted in Region Örebro County, Sweden. The study uses existing medical records and does not assign interventions or alter patients' clinical care.
The study population comprises adults aged 18 years or older hospitalized during the period September 2024 through September 2026 with a registered diagnosis of aspiration pneumonia. Patients will be identified through diagnostic coding. The planned primary cohort includes each eligible patient once; subsequent admissions will be handled as follow-up events rather than as new primary cohort observations.
Data collection
Data will be collected through structured review of existing medical records using a predefined data collection form. Variables will include:
Demographic characteristics, living situation, functional status, cognition, communication, nutritional status, and relevant comorbidities.
Risk factors for aspiration and the documentation and classification of the suspected or documented aspiration event.
Clinical presentation, vital signs, laboratory results, radiological findings, and microbiological investigations.
Antibiotic treatment, including antibiotic selection, broad- or narrow-spectrum treatment, anaerobic coverage, treatment duration, changes in treatment, and treatment at discharge where documented.
Other healthcare interventions, clinical deterioration, level of care, intensive or intermediate care, and length of hospital stay.
Discharge destination and follow-up outcomes, including readmission, a new documented episode of aspiration pneumonia, and death within 90 days, where information is available in the records.
Only information documented in the medical record will be recorded. Missing or undocumented information will not be inferred by the reviewer.
Outcomes and analyses
The study will primarily provide a descriptive characterization of the cohort and its clinical course. Analyses will summarize patient characteristics, aspiration-related risk factors, diagnostic investigations, microbiological findings, antibiotic treatment patterns, healthcare utilization, and clinical outcomes.
Exploratory analyses will examine associations between patient and disease characteristics, diagnostic findings, treatment patterns, and documented outcomes where the available data and number of outcome events permit. Antibiotic treatment patterns, including anaerobic coverage and treatment duration, will be described to characterize clinical practice and variation. The study is not designed to establish causal treatment effects or determine which antibiotic regimen is superior.
Ethical considerations
The study involves retrospective review of existing medical records. Ethical review and the necessary approvals will be obtained before the medical record review begins. Data will be handled in accordance with applicable Swedish requirements for research ethics, confidentiality, and personal data protection. Study data will be coded using study-specific identifiers, and direct identifiers will not be included in the analysis dataset.
Purpose and expected contribution
The study aims to provide a structured description of adults hospitalized with aspiration pneumonia in Region Örebro County. It is expected to identify patterns in patient characteristics, diagnostic practice, treatment, clinical course, and outcomes, as well as limitations in the completeness of routinely documented data. The findings will inform future research and the development of more standardized data collection, with particular relevance to older adults, functional outcomes, and healthcare needs.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Karolina Liljedahl Prytz, MD, PhD
- Telefoonnummer: +46196021000
- E-mail: karolina.liljedahl-prytz@regionorebrolan.se
Studie Locaties
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Örebro, Zweden
- Örebro University Hospital
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Contact:
- Karolina Liljedahl Prytz, MD, PhD
- Telefoonnummer: +46196021000
- E-mail: karolina.liljedahl-prytz@regionorebrolan.se
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
The study population consists of adults aged 18 years or older hospitalized in Region Örebro County, Sweden, with a registered diagnosis of aspiration pneumonia during September 2024 through September 2026. Patients will be identified retrospectively through medical records and diagnostic coding. The study will describe patient characteristics, aspiration risk factors, diagnostic findings, antibiotic treatment, and clinical outcomes.
Beschrijving
Inclusion Criteria:
- Adults aged 18 years or older.
- Hospitalized in Region Örebro County, Sweden, during the study period September 2024 through September 2026.
- Registered diagnosis of aspiration pneumonia (ICD-10 code J69.0), subject to the study's final case-identification criteria.
Exclusion Criteria:
- Patients transferred to or from another hospital when the transfer results in insufficient medical record data to assess the study variables and follow-up outcomes.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: RETROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Retrospective Aspiration Pneumonia Cohort
Adults aged 18 years or older hospitalized in Region Örebro County, Sweden, with a registered diagnosis of aspiration pneumonia during September 2024 through September 2026. Eligible patients will be identified through diagnostic coding and described using retrospectively collected medical record data. Each patient will be included once in the primary cohort; subsequent admissions will be handled as follow-up events. |
Antibiotic treatment is not assigned by the study. Existing medical records will be reviewed to describe antibiotic treatment provided as part of routine clinical care, including antibiotic selection, broad- or narrow-spectrum treatment, anaerobic coverage, treatment duration, changes in treatment, and treatment at discharge where documented. These data will be used to characterize clinical practice and variation in treatment patterns. The study is not designed to establish causal treatment effects or determine the superiority of any antibiotic regimen.Kopiera beskrivning
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
All-cause mortality within 30 days
Tijdsspanne: Within 30 days after the date of the index hospital admission.
|
Proportion of patients who die from any cause within 30 days of the index hospital admission for aspiration pneumonia. |
Within 30 days after the date of the index hospital admission.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
In-hospital clinical deterioration
Tijdsspanne: From the date of index hospital admission until discharge from the index hospitalization, up to a maximum of 90 days.
|
In-hospital clinical deterioration during the index hospital admission. |
From the date of index hospital admission until discharge from the index hospitalization, up to a maximum of 90 days.
|
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All-cause mortality within 90 days
Tijdsspanne: From the date of the index hospital admission through 90 days after admission.
|
All-cause mortality within 90 days |
From the date of the index hospital admission through 90 days after admission.
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Hospital readmission within 90 days
Tijdsspanne: Up to 90 days after discharge from the index hospitalization.
|
Proportion of patients with at least one hospital readmission within 90 days after discharge from the index hospitalization. |
Up to 90 days after discharge from the index hospitalization.
|
|
Length of hospital stay
Tijdsspanne: From hospital admission to discharge for the index admission.
|
Duration of the hospital admission, measured in days from hospital admission to hospital discharge. |
From hospital admission to discharge for the index admission.
|
|
New documented aspiration pneumonia within 90 days
Tijdsspanne: From the date of the index hospital admission through 90 days after admission.
|
Proportion of patients with at least one new episode of aspiration pneumonia documented in the medical record within 90 days after discharge from the index hospital admission. |
From the date of the index hospital admission through 90 days after admission.
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Luchtweginfecties
- Infecties
- Ziekten van de luchtwegen
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Longziekten
- Slokdarmaandoeningen
- Longontsteking
- KNO-ziekten
- Faryngeale ziekten
- Verslikkingsstoornissen
- Longontsteking, aspiratie
- Anti-infectieuze middelen
- Farmacologische acties
- Chemische acties en gebruik
- Therapeutisch gebruik
- Antibacteriële middelen
Andere studie-ID-nummers
- ASPEN
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Individual participant data will not be shared with other researchers. The study uses data extracted retrospectively from medical records, and sharing individual-level data is not planned due to patient confidentiality, data protection requirements, and applicable regional regulations. Only aggregated study results may be reported in scientific publications.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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