Pneumonia, AspirationNCT07395310
The Clinical Application Value of "Showering Cells" in the Diagnosis of Aspiration Pneumonia
An observational study of Pneumonia, Aspiration, run by Chinese PLA General Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pneumonia, Aspiration
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2029
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Aged 18 to 100 years, inclusive. No absolute contraindications to bronchoscopy and consent to undergo flexible bronchoscopy.
- 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.).
- 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%).
Show all 13Show fewer
- 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%).
- 3.Exclusion: Does not meet the diagnostic criteria for aspiration pneumonia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Case-Control Study on the Clinical Application Value of "Showering Cells" in the Diagnosis of Aspiration Pneumonia
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.
- Conditions
- Pneumonia, Aspiration
- Keywords
- Pneumonia, Aspiration, microbiological rapid on-site evaluation (M-ROSE)
- 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 with aspiration pneumonia confirmed by the composite gold standard | |
| 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.
the count of "showering cells"
The M-ROSE examination results of BALF, specifically the count of "showering cells" across 30 high-power fields.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Jan 2026
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
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
- 94 participants (estimated)
- 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
- NCT07395310
- Sponsor's protocol ID
- S2025-1035-01
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2026
- Last updated
- 9 Feb 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-Control Study on the Clinical Application Value of "Showering Cells" in the Diagnosis of Aspiration Pneumonia
- ClinicalTrials.gov ID
- NCT07395310
- Acronym / sponsor ID
- S2025-1035-01
- Conditions
- Pneumonia, Aspiration
- Keywords
- Pneumonia, Aspiration, microbiological rapid on-site evaluation (M-ROSE)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Feb 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.
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.
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 with aspiration pneumonia confirmed by the composite gold standard |
| 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 (13 listed)
- Aged 18 to 100 years, inclusive. No absolute contraindications to bronchoscopy and consent to undergo flexible bronchoscopy.
- 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.).
Key exclusion criteria (3 listed)
- 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.
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
the count of "showering cells"
Time frame: Day 2
The M-ROSE examination results of BALF, specifically the count of "showering cells" across 30 high-power fields.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Pneumonia, Aspiration
Recruiting
The Effects of Wintergreen Essential Oil Inhalation on Alleviating Dyspnea Among Patients With Pneumonia
Pneumonia, Dyspnea
RecruitingPhase 1/2
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
RecruitingPhase 4
Gastrointestinal Dysmotility on Aspiration Risk
Esophageal Motility Disorders, Gastric Motor Dysfunction
Not yet recruitingObservational study
Surveillance of Neonatal Endotracheal Tube Colonisation
Ventilation, Mechanical, Ventilation-Associated Pneumonia
Not yet recruiting
Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia
Acute Ischemic Stroke, Stroke-Associated Pneumonia (SAP)
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 13 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Feb 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?
This study is still under way. Results are not available in the source record yet.
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?
the count of "showering cells" (time frame: Day 2). 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 9 Feb 2026.