NCT07395310

The Clinical Application Value of "Showering Cells" in the Diagnosis of Aspiration Pneumonia

Active, enrolled Last updated 9 February 2026

What this trial tests

trial in Pneumonia, Aspiration in 94 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2026

Primary endpoint
31 October 2029

31 December 2029

Quick facts

Lead sponsor	Chinese PLA General Hospital
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	94
Start date	1 January 2026
Primary completion	31 October 2029
Estimated completion	31 December 2029
Sites	1 location across China

Conditions studied

• Pneumonia, Aspiration — all drugs for Pneumonia, Aspiration →

Sponsor

Chinese PLA General Hospital

Who can join

Adults 18 to 100, any sex, with Pneumonia, Aspiration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Based on our team's previous discovery of a unique type of squamous epithelial cell in the bronchoalveolar lavage fluid (BALF) of patients with aspiration pneumonia (AP) using microbiological rapid on-site evaluation (M-ROSE) technology-characterized by its distinct morphology and absence of bacterial adhesion on the surface-which we termed "showering cells," we designed a diagnostic test case-control study. Adult patients with pulmonary infection scheduled to undergo bronchoscopy were screened and allocated into an AP group (experimental group) and a non-AP group (control group). BALF sampling and M-ROSE slide preparation were performed following a standardized protocol. Microscopic examination was conducted to detect and manually count "showering cells." Simultaneously, a committee of respiratory and critical care medicine experts determined the gold-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 their 95% confidence intervals, and the kappa agreement rate. A receiver operating characteristic (ROC) curve was plotted to evaluate the diagnostic performance of "showering cells" for aspiration pneumonia, from which the area under the curve (AUC) was calculated and the optimal cutoff value determined. This study aims to assess the diagnostic utility of "showering cells" and provide a novel cytomorphological tool for the diagnosis of aspiration pneumonia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.