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

NCT ID: NCT05846607

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2023-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastic Antrum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Intervention oral supplement

Intervention Type DIETARY_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

le tian wang

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Le tian Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University affiliated Huashan Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fudan University affiliated Huashan Hospital

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Le tian Wang, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Le tian Wang

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-491

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gastric Ultrasound Versus Gastroscopic Aspiration
NCT07292935 NOT_YET_RECRUITING NA