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

April 27, 2023 updated by: le tian wang, Huashan Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Fudan University Affiliated Huashan Hospital
        • Contact:
          • Le tian Wang

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

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experiment

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.
Dietary supplement: Intervention oral supplement
The oral supplement used as intervention for the study will be DongzheSutang(DAISY FSMP,Jiangsu,China). The formula contains only carbohydrate:12.5g in 100ml of product(glucose syrup and maltodextrin)，with a caloric density of 16.32kcal/g.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic accuracy of the model
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Le tian Wang, MD, Fudan University Affiliated Huashan Hospital

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)

April 26, 2023

Primary Completion (Anticipated)

September 15, 2023

Study Completion (Anticipated)

September 15, 2023

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Estimate)

May 5, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-491

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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