Brief Summary

Pulmonary aspiration of gastric contents is a complication responsible for the third highest cause of anaesthesia-related mortality in France, and for 50% of airway management-related mortality in the UK. The occurrence of pulmonary aspiration of gastric contents is often the result of a poor assessment of the risk of a "full" stomach, and could therefore often be avoided if the preoperative gastric contents were known to the anaesthetist. It is therefore useful to be able to discriminate easily between patients at risk of aspiration and those at low risk before general anaesthesia, and this can be done by ultrasound examination of the gastric contents in the gastric antrum, non-invasively (abdominal ultrasound) using a 2-5 MHz abdominal ultrasound probe or a high-frequency linear probe in small children (under 10 kg). European recommendations on preoperative fasting in paediatrics recommend that the examination should be interpreted in a qualitative manner only, without measuring the antral surface. However, the diagnostic performance of this qualitative approach alone has never been evaluated. The aim of this study was to determine the diagnostic performance of the qualitative assessment of gastric contents by ultrasound in children, and to compare it with that of the clinical algorithm, for the detection of a volume of fluid greater than 1.25 ml/kg. Children will present themselves in the morning after fasting. Upon arrival, if their weight is not known, the children will be weighed. Subsequently, they will be positioned on an examination table in a supine inclined position at 45° (head of the bed elevated). An initial gastric ultrasound will be performed by a physician (investigator 1) who will not conduct the study ultrasounds. This initial ultrasound aims to confirm the absence of gastric content in the supine and right lateral decubitus positions, thereby establishing gastric emptiness. Investigator 1 will then proceed with the random selection of the clear liquid volume to be ingested for the study. The child will then be asked to drink this determined volume of clear liquid (water or apple juice according to their preference), as per the randomization results, under the supervision of the first investigator who performed the initial ultrasound. Subsequently, investigator 2 will perform a gastric ultrasound blindly with respect to the ingested liquid volume, three minutes after the consumption of the clear liquid. The examination will last a maximum of 3 minutes. Non-invasive gastric antrum ultrasound examinations will utilize a probe with a frequency of 2-5.5 MHz and a linear probe with a frequency of 10 MHz, enabling the evaluation of the gastric antrum's appearance. The diameters (longitudinal D1 and anteroposterior D2) of the antrum will also be measured in the supine (semi-seated and lying) and right lateral positions in the sagittal plane passing through the abdominal aorta and the left lobe of the liver, for the calculation of the antral section area, given by the formula: Antral area = π x D1 x D2 / 4.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 months study duration

First Submitted

Initial submission to the registry

October 6, 2023

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed

2 months until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

October 6, 2023

Last Update Submit

September 2, 2025

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

Sensitivity and specificity of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 1.25 ml/kg in the 45° semirecumbent position
Calculation of the sensitivity and specificity
3 minutes after the ingestion of water

Secondary Outcomes (2)

Positive predictive value, negative predictive value, positive and negative likelihood ratio of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 1.25 ml/kg in the 45° semirecumbent position
3 minutes after the ingestion of water
Diagnostic performance of a clinical algorithm used for the interpretation of gastric ultrasound for the detection of gastric fluid volume ≥ 1.25 ml/kg in the 45° semirecumbent position
3 minutes after the ingestion of water

Study Arms (6)

0 ml/kg of water

EXPERIMENTAL

The child does not drink water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume.