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Pneumonia, AspirationNCT07707206

Preliminary Study on the Clinical Application Value of "Showering Cells" in Diagnosing Aspiration Pneumonia

An observational study of Pneumonia, Aspiration, run by Chinese PLA General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Pneumonia, Aspiration
How many people
430 participants
Where
1 siteChina
Study dates
12 Jan 2018to 21 Mar 2026
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

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

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.

Read more

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.

Keywords
pneumonia, aspiration, showering cell, bronchoalveolar lavage fluid, diagnostic marker, Rapid On-Site Evaluation
Medical subject headings
Pneumonia, Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07707206
Study groupRoleWhat they receive
AP GroupAdult patients who were definitively diagnosed with pulmonary infection and met the diagnostic criteria for aspiration pneumonia.
non-AP GroupAdult patients with pulmonary infection not diagnosed as aspiration pneumonia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. showering cells count

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

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

  2. showering cells proportion

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start12 Jan 2018
  3. Primary completion31 Dec 2024
  4. Study completion21 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
430 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT07707206
Sponsor's protocol ID
Aspiration Pneumonia
Status last verified
Jul 2026
First submitted
29 Jun 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumonia, Aspiration, run by Chinese PLA General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

showering cells count (time frame: The first Rapid On-Site Evaluation result within 48 hours of the patient's admission.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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