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.
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.
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.
- Conditions
- Pneumonia, Aspiration
- 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 group | Role | What they receive |
|---|---|---|
| AP Group | Adult patients who were definitively diagnosed with pulmonary infection and met the diagnostic criteria for aspiration pneumonia. | |
| non-AP Group | Adult 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.
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.
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.
- First posted16 Jul 2026
- Study start12 Jan 2018
- Primary completion31 Dec 2024
- Study completion21 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, AspirationStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Showering Cells in Aspiration Pneumonia: A Retrospective Case-control Study
- ClinicalTrials.gov ID
- NCT07707206
- Acronym / sponsor ID
- Aspiration Pneumonia
- Conditions
- Pneumonia, Aspiration
- Keywords
- pneumonia, aspiration, showering cell, bronchoalveolar lavage fluid, diagnostic marker, Rapid On-Site Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 21 Mar 2026 (actual)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP Group | – | –Adult patients who were definitively diagnosed with pulmonary infection and met the diagnostic criteria for aspiration pneumonia. |
| non-AP Group | – | –Adult patients with pulmonary infection not diagnosed as aspiration pneumonia |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients with confirmed lung infection admitted to Chinese PLA General Hospital.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
showering cells count
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.