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临床试验/NCT07707206
NCT07707206已完成不适用

Diagnostic Value of Showering Cells in Aspiration Pneumonia: A Retrospective Case-control Study

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2018年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
430
试验地点
1
主要终点
showering cells count

研究概览

简要总结

Study Design and Participants: This single-center, retrospective case-control study enrolled adult patients (18-100 years) hospitalized in the RICU of the Chinese PLA General Hospital between January 2018 and December 2024, who were clinically diagnosed with pulmonary infection and underwent both bronchoalveolar lavage (BAL) and rapid on-site evaluation (ROSE) examination. Exclusion criteria included age outside the range, non-infectious pulmonary diseases, absence of bronchoscopy/BAL, unqualified ROSE specimens (poor image quality or substandard samples), or missing critical clinical data for grouping.

Diagnostic Criteria and Grouping: Aspiration pneumonia (AP) was diagnosed using a clinical-imaging composite gold standard. The AP group had to simultaneously meet: (1) chest CT showing new gravitationally-dependent infiltrates; (2) a definite aspiration history or at least one high-risk factor (e.g., impaired consciousness, swallowing dysfunction, gastroesophageal reflux, diminished cough/gag reflex, poor oral hygiene); and (3) ≥2 of the following infection criteria: fever (>38.0°C or <36.0°C), new/worsened respiratory symptoms or purulent secretions with gastric contents, and abnormal peripheral white blood cell count or left shift. The non-AP group comprised patients with ≥2 infection criteria but who did not meet the AP diagnostic criteria.

ROSE Procedure and Definition of "Showering Cells": BALF was submitted for testing within 30 minutes, centrifuged, and the sediment smeared onto slides for Gram and Diff-staining. A blinded morphologist assessed specimen adequacy and performed microscopic examination. "Showering cells" were defined as squamous epithelial cells observed under high-power fields (×1000) with the distinct morphology of no bacterial adhesion on the surface, clear cytoplasm, and a clean background. Ten non-overlapping high-power fields were randomly selected to count the total number of showering cells and total squamous epithelial cells, and the showering cell ratio (showering cells / total squamous epithelial cells) was calculated.

Data Collection: Demographic data, aspiration risk factors, imaging features, inflammatory markers (white blood count, neutrophil percentage, C-reactive protein, Interleukin-6,Procalcitonin), showering cell-related indicators, underlying diseases, and respiratory/nutritional support modalities were collected.

Statistical Methods: Continuous variables were expressed as median (IQR) and compared using the Mann-Whitney U test; categorical variables were compared using the χ² or Fisher's exact test. For multivariate analysis, multiple imputation and complete case analysis were jointly used to construct logistic regression models (controlling for confounders, VIF<5), calculating adjusted odds ratios (aOR) and 95% CIs, with the showering cell ratio scaled by a factor of 10. Diagnostic performance was evaluated via ROC curves (AUC), with the optimal cutoff determined by the Youden index; AUCs were compared using the DeLong test, and internal validation was performed using the Bootstrap method (1000 resamples). For incremental value assessment, a baseline model (core clinical variables) and a combined model (adding showering cell indicators) were constructed. Discriminative ability was compared via AUC, calibration was assessed by calibration curves and mean absolute error, and reclassification improvement was quantified using NRI and IDI. Decision curve analysis (DCA) was applied to evaluate clinical net benefit, and a nomogram was ultimately constructed based on the optimal model. A two-sided P <0.05 was considered statistically significant.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-100 years;
  • Clinically confirmed pulmonary infection;
  • Completion of bedside BAL;
  • Qualified BALF specimens submitted for M-ROSE examination;
  • Complete clinical and radiological data.

排除标准

  • Age <18 years or >100 years;
  • Diagnosis of noninfectious pulmonary diseases;
  • No bronchoscopy or BAL examination;
  • BALF samples not assessed by M-ROSE, acquired images were of poor quality, or samples were unqualified;
  • Missing key clinical data precluded group assignment.

结局指标

主要结局

showering cells count

时间窗: The first Rapid On-Site Evaluation result within 48 hours of the patient's admission.

The total number of "showering cells" in the 10 fields was counted and recorded as the showering cell count

showering cells proportion

时间窗: The first Rapid On-Site Evaluation result within 48 hours of the patient's admission.

The proportion of showering cells was calculated by dividing the number of showering cells by the total number of squamous epithelial cells, both counted in the same 10 high-power fields.

次要结局

未报告次要终点

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

wang kaifei

Chief Physician

Chinese PLA General Hospital

研究点 (1)

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