Official Title
A Case-Control Study on the Clinical Application Value of "Showering Cells" in the Diagnosis of Aspiration Pneumonia
Brief Summary

Based on our team's previous discovery of a unique type of squamous epithelial cell inthe bronchoalveolar lavage fluid (BALF) of patients with aspiration pneumonia (AP) usingmicrobiological rapid on-site evaluation (M-ROSE) technology-characterized by itsdistinct morphology and absence of bacterial adhesion on the surface-which we termed"showering cells," we designed a diagnostic test case-control study. Adult patients withpulmonary infection scheduled to undergo bronchoscopy were screened and allocated into anAP group (experimental group) and a non-AP group (control group). BALF sampling andM-ROSE slide preparation were performed following a standardized protocol. Microscopicexamination was conducted to detect and manually count "showering cells." Simultaneously,a committee of respiratory and critical care medicine experts determined thegold-standard diagnosis (AP or non-AP) based on composite clinical criteria.A 2×2 contingency table was constructed to calculate sensitivity, specificity,positive/negative likelihood ratios, positive/negative predictive values along with their95% confidence intervals, and the kappa agreement rate. A receiver operatingcharacteristic (ROC) curve was plotted to evaluate the diagnostic performance of"showering cells" for aspiration pneumonia, from which the area under the curve (AUC) wascalculated and the optimal cutoff value determined. This study aims to assess thediagnostic utility of "showering cells" and provide a novel cytomorphological tool forthe diagnosis of aspiration pneumonia.

Detailed Description

Not Provided

Active, not recruiting
Pneumonia, Aspiration
Eligibility Criteria

Inclusion Criteria:

- Aged 18 to 100 years, inclusive. No absolute contraindications to bronchoscopy and
consent to undergo flexible bronchoscopy.

Hospitalized patients who either meet the diagnostic criteria for aspiration pneumonia or
have aspiration pneumonia definitively ruled out.

AP Group:

1. Imaging Findings:Newly developed dependent infiltrates on chest CT
(gravity-dependent distribution of new lung infiltrates). Specifically, in the
standing/sitting position, infiltrates are predominantly seen in the basal segments
of the lower lobes, especially the right lower lobe. In the supine position,
infiltrates are primarily located in the posterior segment of the right upper lobe
and the dorsal segment of the right lower lobe. These may be accompanied by a small
amount of pleural effusion or plate-like atelectasis.

2. Clinical History Characteristics:A clear history of aspiration or the presence of at
least one high-risk factor for aspiration (e.g., impaired consciousness: sedated
state, post-stroke, epileptic seizure; confirmed swallowing dysfunction;
gastroesophageal reflux disease; abnormal gag reflex/diminished cough reflex; poor
oral hygiene: periodontitis, inadequate denture cleaning; end-stage disease:
advanced dementia, malignancy, etc.).

2.Meeting 2 or more of the following 3 clinical criteria:(1).Temperature abnormality:
Fever (core temperature >38.0°C) or hypothermia (core temperature <36.0°C, more common in
elderly or immunocompromised patients).(2).Respiratory symptoms: New onset or worsening
of cough, production of purulent sputum (may contain food particles or unusual odor),
dyspnea, chest pain, or detection of food particles/gastric contents in tracheal
secretions.(3).Abnormal peripheral inflammatory markers: White blood cell count >10×10⁹/L
or <4×10⁹/L, or presence of a left shift (band neutrophil proportion >5%).

Non-AP Group:

1. Imaging: Chest CT reveals newly appeared or progressive pulmonary infiltrates,
consolidation, or ground-glass opacities.

2. Clinical Criteria: Meeting 2 or more of the following 3 criteria:

(1).Fever (core temperature >38.0°C) or hypothermia (core temperature <36.0°C, more
common in elderly or immunocompromised patients).

(2).Respiratory symptoms: Purulent or mucopurulent sputum, possibly with blood-streaked
sputum; or new/worsening cough and sputum production; or accompanied by chest pain or
dyspnea.

(3).Abnormal peripheral white blood cell count: Total white blood cell count >10×10⁹/L or
<4×10⁹/L, or presence of a left shift (band neutrophil proportion >5%).

3.Exclusion: Does not meet the diagnostic criteria for aspiration pneumonia.

Exclusion Criteria:

1. Younger than 18 years old or older than 100 years old.

2. Patients with absolute contraindications to performing bronchoscopy with
bronchoalveolar lavage (BAL);

3. Patients who refuse to participate in the study.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 100 Years
Countries
China
Locations

Chinese PLA General Hospital
Beijing, Beijing Municipality, China

Not Provided

Chinese PLA General Hospital
NCT Number
Keywords
Pneumonia, Aspiration
microbiological rapid on-site evaluation (M-ROSE)
MeSH Terms
Pneumonia, Aspiration