NCT07395310

Active Not Recruiting

The Clinical Application Value of "Showering Cells" in the D...

Chinese PLA General Hospital Source

Compare

Other study identifiers

Sponsor study identifier

S2025-1035-01

Study Type

observational

Estimated enrollment

94

Locations

1 country

Sites

1

Timeline

Study Start

January 1, 2026

Actual (reported)

Primary Completion

October 31, 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Estimated enrollment: 94 participants
Study completion date: December 31, 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 1, 2026
Actual (reported)
First Submitted
February 1, 2026
Actual (reported)
First Posted
February 9, 2026
Actual (reported)
Primary Completion
October 31, 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: February 9, 2026
Status Verified: January 2026
Last Update Submitted: February 6, 2026

Conditions

Pneumonia, Aspiration

Keywords

Pneumonia, Aspirationmicrobiological rapid on-site evaluation (M-ROSE)

Outcome Measures

Primary Outcomes (1)

the count of "showering cells"
The M-ROSE examination results of BALF, specifically the count of "showering cells" across 30 high-power fields.
Day 2

Study Arms (2)

AP Group

Adult patients with aspiration pneumonia confirmed by the composite gold standard

Non-AP Group

Adult patients with pulmonary infection not diagnosed as aspiration pneumonia

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Inpatients with confirmed lung infection admitted to Chinese PLA General Hospital.

You may qualify if:

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

Sponsors & Collaborators

Chinese PLA General Hospital
Otherlead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: CROSS SECTIONAL
Target Duration: 1 Month
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Chief Physician

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 9, 2026

Study Start

January 1, 2026

Actual (reported)

Primary Completion

October 31, 2029

Estimated

NCT06666049

Gastric POCUS for Airway Management in Patients Using Glucagon-like Peptide-1 Receptor Agonist (Multicentric)

Recruiting

NCT00000362

Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects

Phase 3Terminated

NCT05810688

Eating Rehabilitation Training for Timely Removal of Nasogastric Tube in Elderly Patients

Not ApplicableUnknown

NCT03844568

Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia

Not ApplicableWithdrawn

NCT03763799

Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation

Not ApplicableCompleted

NCT04157998

Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section

Not ApplicableUnknown

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

AP Group：

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.

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.).

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:

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

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%).

You may not qualify if:

Younger than 18 years old or older than 100 years old.
Patients with absolute contraindications to performing bronchoscopy with bronchoalveolar lavage (BAL);
Patients who refuse to participate in the study.

Contact the study team to confirm eligibility.

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

February 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07395310
Data provider: ClinicalTrials.gov
Source updated: 2026-02-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:50 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

AP Group

Non-AP Group

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations