Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000, China
NCT Number: NCT07395310
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–100 year
All sexes
Observational
Beijing, Beijing Municipality, 100000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Hospitalized patients who either meet the diagnostic criteria for aspiration pneumonia or have aspiration pneumonia definitively ruled out.
AP Group:
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).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
Time frame: Day 2
The M-ROSE examination results of BALF, specifically the count of "showering cells" across 30 high-power fields.
Chinese PLA General Hospital
Other
A Case-Control Study on the Clinical Application Value of "Showering Cells" in the Diagnosis of Aspiration Pneumonia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07707206
Infections, Lung Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT07627399
Acute Stroke, Body Temperature Changes
Antequera, Málaga, Spain
View Trial DetailsNCT06705894
Infections, Lung Diseases
Qingdao, Shangdong, China
View Trial DetailsNCT06154486
Anesthesia, Infections
São Paulo, Brazil
View Trial Details