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Aspiration Pneumonia in Adults: Patient Characteristics, Diagnosis, Treatment, and Outcomes (ASPEN)

11 novembre 2026 aggiornato da: Region Örebro County

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

300

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: RETROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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

Altri nomi:
  • Antibiotics; Antimicrobial therapy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All-cause mortality within 30 days
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
In-hospital clinical deterioration
Lasso di tempo: 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.
All-cause mortality within 90 days
Lasso di tempo: 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.
Hospital readmission within 90 days
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

5 gennaio 2027

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

26 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 novembre 2026

Primo Inserito (Effettivo)

12 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • ASPEN

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .