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Clinical Trials/NCT05846607
NCT05846607RecruitingNot Applicable

A Deep Learning Approach to Identify Patients With Full Stomach on Ultrasonography

Huashan Hospital1 site in 1 country800 target enrollmentStarted: April 26, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
800
Locations
1
Primary Endpoint
Diagnostic accuracy of the model

Study Overview

Brief Summary

Preoperative gastric ultrasonography is a newly developed tool used to evaluate gastric content and volume in assessing perioperative aspiration risk and guide anaesthetic management. And then build up effective clinical predictive models for identification of full stomach, which can predict the high aspiration risk.

Detailed Description

Aspiration of gastric contents can be a serious anesthetic related complication. Preoperative fasting was a common practice to decrease perioperative aspiration risk. However,one of most important prescription of enhanced recovery after surgery protocols is the reduction of preoperative fasting time in opposition to the traditional recommendation of overnight fast. Gastric antral sonography prior to anesthesia may have a role in identifying patients at risk of aspiration. The aim of this study is to construct models using deep learning for identification of full stomach, which can predict the aspiration risk.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients undergoing surgery Age: 18~85 yeas ASA 1~3

Exclusion Criteria

  • •Diabetes mellitus Upper gastrointestinal pathology such as hiatus hernia, oesophageal cancer Prior surgery to upper GI On medication that may affect gastric emptying time Pregnancy

Arms & Interventions

experiment

Experimental

The data will be collected in two phases. Firstly, after a fasting period of eight hours, the participants received ultrasound scan by expert doctor with the objective of measuring the fasting gastric antrum area in supine and right lateral decubitus(RLD)position(phase 1).Then the expert made the grading according to the ultrasound image.

In phase 2, the participant will ingest 0 to 400ml of the study drink described below randomly. The individual will be immediately positioned in the supine position and another ultrasound scan will be carried out. Again in the RLD position.

Intervention: Intervention oral supplement (Dietary Supplement)

Outcomes

Primary Outcomes

Diagnostic accuracy of the model

Time Frame: 1 year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

le tian wang

Doctor

Huashan Hospital

Study Sites (1)

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