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A Study on Risk Prediction and Intervention Evaluation of Bedside Combined Lung, Diaphragm and Stomach Ultrasound in Emergency Populations at High Risk of Aspiration

A Study on Risk Prediction and Intervention Evaluation of Bedside Combined Lung, Diaphragm and Stomach Ultrasound in Emergency Populations at High Risk of Aspiration

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129375
Enrollment
Unknown
Registered
2026-08-04
Start date
2026-08-10
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspiration Pneumonia

Interventions

High-risk aspiration emergency observation group:Bedside combined ultrasound evaluation of lung, diaphragm and gastric antrum for emergency patients at high risk of aspiration, no additional clinical

Sponsors

General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Subjects were patients admitted to the Emergency Resuscitation Room of The Eastern Theater General Hospital between August 2026 and May 2027. Patients satisfying at least one of the following high-risk factors were eligible for enrollment: 1. Altered mental status (Glasgow Coma Scale score = 3, or hyoid bone movement amplitude = 2 episodes of hematemesis/melena per day, or a hemoglobin drop of >= 20 g/L from baseline); 5. Aged >= 65 years, complicated with stroke onset within the past 6 months, or severe chronic obstructive pulmonary disease (COPD): long-term oxygen therapy >= 15 hours daily for at least 1 consecutive month, or >= 2 hospital admissions for acute exacerbation within the preceding year; 6. Confirmed history of aspiration pneumonia within the past 12 months; 7. Impaired cough reflex: Cough strength score 340 mm² on ultrasonography; 9. Continuous administration of sedatives (midazolam), neuromuscular blocking agents (rocuronium bromide), or antipsychotics (olanzapine) for >= 24 hours within the preceding 72 hours; 10. Diagnosed neuromuscular diseases such as Parkinson’s disease or myasthenia gravis, accompanied by choking during feeding and other dysphagia manifestations.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: 1. Contraindications to ultrasound examination (e.g., open thoracic and abdominal trauma); 2. Terminal illness with an expected survival time less than 24 hours; 3. History of gastrointestinal surgery that interferes with visualization of the gastric antrum, including subtotal gastrectomy (resection volume > 50%), gastric bypass, and gastrojejunostomy; 4. Pre-existing aspiration pneumonia confirmed by CT scan prior to enrollment; 5. Body mass index (BMI) > 40, with poor visualization of the gastric antrum despite optimized scanning protocols (combined high-frequency linear probe 7–10 MHz and convex probe 3–5 MHz, probe angle adjustment and compression scanning); 6. Concurrent esophageal varices, which may cause measurement bias of gastric antral cross-sectional area (CSA).

Design outcomes

Primary

MeasureTime frame
Incidence of aspiration within 24 hours after enrollment;Sensitivity, specificity, optimal cut-off value;

Secondary

MeasureTime frame
Recurrence rate of aspiration within 72 hours after enrollment;Incidence of Ventilator-Associated Pneumonia (VAP);28-day all-cause mortality;Length of ICU stay;Duration of invasive mechanical ventilation;Parameters of bedside lung-diaphragm-stomach ultrasound;Area under ROC curve (AUC) for discrimination;Calibration curve, Hosmer-Lemeshow test;Internal validation by 1000-time Bootstrap resampling;Decision curve analysis (DCA);Nomogram prediction model;

Countries

China

Contacts

Public ContactNie Shinan

General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army

yueshi5@126.com+86 138 1390 4009

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026