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Completed

NCT Number: NCT07640165

Gastric Ultrasound for Airway Management in Emergency Patients

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.

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Key information

Conditions

Pulmonary Aspiration of Gastric Contents Airway Management Deglutition Disorders Digestive System Diseases Disease Attributes Emergencies Emergency Surgery Esophageal Diseases Esophageal Motility Disorders Gastric Residual Volume Gastroesophageal Reflux Gastrointestinal Diseases Laryngopharyngeal Reflux Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Aspiration of Gastric Contents Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RSUPN Cipto Mangunkusumo

Jakarta, Jakarta Special Capital Region, 01430, Indonesia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative Gastric Point-of-Care Ultrasound (PoCUS)

Device

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: Gastric USG, Gastric Ultrasound, Bedside Gastric Sonography

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Airway Management Selection Based on Gastric Content and Residual Volume Assessment in Emergency Patients at RSCM: An Ultrasonography Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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