- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07640165
Gastric Ultrasound for Airway Management in Emergency Patients
June 8, 2026 updated by: Raden Besthadi Sukmono, Indonesia University
Airway Management Selection Based on Gastric Content and Residual Volume Assessment in Emergency Patients at RSCM: An Ultrasonography Study
This prospective observational cohort study evaluates the association between gastric residual content and volume, assessed by point-of-care gastric ultrasound (PoCUS), and the choice of airway management technique (Rapid Sequence Intubation vs. non Rapid Sequence Intubation) in adult emergency surgical patients at Rumah Sakit Cipto Mangunkusumo (RSCM).
Aspiration risk in emergency patients is a critical concern, and this study examines whether objective ultrasonographic findings change clinical decision-making compared to traditional clinical assessment alone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Emergency patients frequently have delayed gastric emptying, increasing aspiration risk during airway management.
Gastric PoCUS allows non-invasive, bedside assessment of gastric content (empty, liquid, solid, or mixed) and volume.
This study quantifies gastric antrum cross-sectional area (CSA) using the Perlas formula (GV = 27.0 + 14.6 × CSA - 1.28 × age) and reports whether USG findings influenced the anesthesiologist's plan (RSI or non-RSI).
Study Type
Observational
Enrollment (Actual)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jakarta Special Capital Region
-
Jakarta, Jakarta Special Capital Region, Indonesia, 01430
- RSUPN Cipto Mangunkusumo
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult emergency surgical patients (age >18 years) requiring airway management under general anesthesia at the Emergency Operating Room of RSUPN Dr. Cipto Mangunkusumo (RSCM), Jakarta, Indonesia.
The population includes both trauma (62.8%) and non-trauma (37.2%) emergency cases.
Patients were enrolled consecutively from July to August 2025.
Patients with conditions that could confound gastric ultrasound assessment or airway management decisions were excluded.
Description
Inclusion Criteria:
- Emergency patients requiring airway management in the Emergency Operating Room
- Age >18 years
Exclusion Criteria:
- Pregnancy
- Morbid obesity (BMI >40 kg/m²)
- History of prior gastric or esophageal surgery
- Duodenal tube in situ
- Maxillofacial trauma or anticipated difficult airway
- Inability to adequately visualize the gastric antrum on ultrasound
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Emergency Surgical Patients
Adult emergency surgical patients (age >18 years) requiring airway management at the Emergency Operating Room of RSUPN Dr. Cipto Mangunkusumo (RSCM), who underwent preoperative gastric point-of-care ultrasound (PoCUS) to assess gastric content type and residual volume prior to anesthetic induction.
|
Gastric antrum ultrasound performed using a low-frequency transducer (2-5 MHz; SonoSite M-Turbo or Lumify Philips) in the supine position before anesthetic induction.
The antrum cross-sectional area (CSA) was measured during the relaxation phase between two peristaltic contractions, calculating cranio-caudal (CC) and antero-posterior (AP) diameters.
Gastric residual volume (GRV) was calculated using the Perlas formula: GV = 27.0 + 14.6 × CSA - 1.28 × age (years).
Gastric content was classified as empty, liquid, solid, or mixed.
Aspiration risk was categorized as high (GRV ≥1.5 ml/kg or solid content) or low (GRV <1.5 ml/kg or empty).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association between aspiration risk based on gastric ultrasound findings and airway management technique selection
Time Frame: At time of pre-induction assessment (single time point, intraoperative)
|
Proportion of patients in whom airway management technique (Rapid Sequence Intubation vs. non Rapid Sequence Intubation) was associated with aspiration risk category (high vs. low) determined by preoperative gastric Point-of-Care Ultrasound (PoCUS) findings.
Aspiration risk classified as high if Gastric Residual Volume (GRV) ≥1.5 ml/kg or solid gastric content; low if GRV <1.5 ml/kg or empty stomach.
Analyzed using chi-square test.
|
At time of pre-induction assessment (single time point, intraoperative)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Airway Management Plan After Gastric USG
Time Frame: Before and immediately after gastric USG, prior to anesthetic induction
|
Comparison of airway management plan (RSI vs. non-RSI) before and after disclosure of gastric USG findings to the treating anesthesiologist.
Analyzed using McNemar's paired categorical test.
|
Before and immediately after gastric USG, prior to anesthetic induction
|
|
Gastric Residual Volume
Time Frame: At pre-induction assessment
|
Gastric residual volume calculated using the Perlas formula: GV = 27.0 + 14.6 × CSA - 1.28 × age (years), based on antrum cross-sectional area (CSA) measured from cranio-caudal (CC) and antero-posterior (AP) diameters.
Reported as mean ± SD or median (range).
|
At pre-induction assessment
|
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Gastric Content Type
Time Frame: At pre-induction assessment
|
Proportion of patients with each gastric content category: empty, liquid only, solid, or mixed (solid and liquid), as identified by gastric PoCUS.
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At pre-induction assessment
|
|
Fasting Duration and Its Relationship to Gastric Residual Volume
Time Frame: At pre-induction assessment
|
Fasting duration categorized as <8 hours, 8-12 hours, or >12 hours since last solid food intake, and its relationship to gastric residual volume and aspiration risk classification on USG.
|
At pre-induction assessment
|
|
American Society of Anesthesiologists (ASA) Physical Status Classification as a factor in airway management decision
Time Frame: At pre-induction assessment
|
Proportion of patients in each American Society of Anesthesiologists (ASA) class (I, II, III, IV) and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG, analyzed using chi-square test.
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At pre-induction assessment
|
|
Trauma Severity Score (ISS) as a factor in airway management decision
Time Frame: At pre-induction assessment
|
Injury Severity Score (ISS) categorized as severe (ISS ≥15) or mild-moderate (ISS <15) and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG, analyzed using chi-square test.
|
At pre-induction assessment
|
|
Glasgow Coma Scale (GCS) score as a factor in airway management decision
Time Frame: At pre-induction assessment
|
GCS score recorded at pre-induction assessment and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG.
|
At pre-induction assessment
|
|
Presence of clinical risk factors (sepsis, shock, GERD/gastritis) as a factor in airway management decision
Time Frame: At pre-induction assessment
|
Proportion of patients with each clinical risk factor (sepsis, hemorrhagic shock, GERD/gastritis) and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG, analyzed using chi-square or Fisher's exact test.
|
At pre-induction assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2025
Primary Completion (Actual)
August 13, 2025
Study Completion (Actual)
September 13, 2025
Study Registration Dates
First Submitted
June 2, 2026
First Submitted That Met QC Criteria
June 8, 2026
First Posted (Actual)
June 10, 2026
Study Record Updates
Last Update Posted (Actual)
June 10, 2026
Last Update Submitted That Met QC Criteria
June 8, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Respiratory Tract Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Respiration Disorders
- Esophageal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Laryngopharyngeal Reflux
- Gastroesophageal Reflux
- Respiratory Aspiration
- Pathological Conditions, Signs and Symptoms
- Emergencies
- Respiratory Aspiration of Gastric Contents
Other Study ID Numbers
- GastricUSG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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