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Gastric Ultrasound Versus Gastroscopic Aspiration

NCT07292935 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1390

Last updated 2025-12-24

No results posted yet for this study

Summary

This is a prospective, single-center observational study conducted at the Fribourg Cantonal Hospital to evaluate the diagnostic performance of preoperative gastric ultrasound in determining gastric content and volume. Upper gastrointestinal endoscopy with complete suction of gastric contents serves as the reference standard.

Adult patients (≥ 18 years) scheduled for elective or urgent gastroscopy are consecutively recruited. A gastric ultrasound is performed within one hour before the endoscopic procedure. The antral cross-sectional area is measured in standardized positions (supine and right lateral decubitus), and gastric volume is estimated using validated formulas. Gastric content is categorized into three grades (empty, low-risk liquid content, or high-risk/solid content).

During gastroscopy, complete aspiration of gastric contents is performed at the start of the procedure. The aspirated volume and qualitative characteristics (liquid vs. solid) are recorded, and the stomach is classified as empty, partially full, or full by the endoscopist.

The primary objective is to determine the accuracy of gastric ultrasound in identifying a full stomach. Secondary objectives include evaluating the qualitative agreement between ultrasound and gastroscopy, correlating estimated gastric volume with aspirated volume, and identifying an optimal ultrasound-based volume threshold predictive of a full stomach.

Approximately 1,390 patients will be enrolled over one year to obtain at least 139 "full stomach" cases, based on prevalence estimates and sample size calculations. Statistical analyses will include diagnostic performance metrics, Cohen's kappa, correlation tests, Bland-Altman plots, and ROC curve analysis.

Conditions

  • Aspiration Risk
  • Full Stomach Status
  • Gastric Content

Interventions

DIAGNOSTIC_TEST

Gastric Ultrasound

All enrolled participants undergo a preoperative gastric ultrasound within one hour prior to the scheduled gastroscopy. The gastric antrum is measured in standardized positions, and estimated gastric volume is calculated.

Sponsors & Collaborators

  • Hôpital Fribourgeois

    lead OTHER

Principal Investigators

  • Hadhami Abdouli, Docteur · Hôpital Cantonal Fribourgeois

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07292935 on ClinicalTrials.gov