AI for Gastric POCUS ( Point-of-care Ultrasound)

NCT07580456 | Not Yet Recruiting

• 1 other identifier: 25-6148
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to train and test an AI (Artificial Intelligence)-based program to assist anesthesiologists in the interpretation of stomach ultrasound images and differentiate a "full" from an "empty" stomach. It is a healthy-volunteer study, where the participants will undergo ultrasound examination of their stomach at three different time points to visualize the stomach contents. These are at fasting state, after taking some solid food and after taking some water. Here, the participants will be randomized to receive one of five different types solid foods and one of five different volumes of water. The stomach ultrasound images will then be used to train and test the accuracy of the model to diagnose the type of stomach content (nothing vs. clear fluid vs. solid food)

Conditions

Point-of-care Ultrasound

Keywords

Artificial Intelligence; POCUS (Point-of-care ultrasound); Ultrasound

Outcome Measures

Primary Outcomes (1)

• To see the overall accuracy of the AI model

  To see the overall accuracy of the AI-enhanced ultrasound model to differentiate no content and clear fluid from solid.

  Through study completion, an average of 2 years

Secondary Outcomes (7)

• To measure the accuracy of the AI model in differentiating a empty from a full stomach

  Through study completion, an average of 2 years

• To measure the balanced accuracy of the AI model

  Through study completion, an average of 2 years

• To measure the precision of the AI model

  Through study completion, an average of 2 years

• To measure the recall of the AI model

  Through study completion, an average of 2 years

• To evaluate the model's classification performance across different confidence thresholds.

  Through study completion, an average of 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult healthy volunteer aged ≥18 years

You may qualify if:

• Aged ≥18 years
• Any sex
• Be healthy
• The edge of the left lobe of the liver
• The gastric antrum
• The pancreas
• The aorta

You may not qualify if:

• Previous gastro-esophageal surgery (e.g., gastric by-pass, sleeve gastrectomy, fundoplication, partial gastrectomy)
• Allergy to any of the food that will be provided.
• Ultrasound images (10 sec clips) where the gastric antrum cannot be positively identified.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Study Officials

• Anahi Perlas

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayanta Chowdhury, MBBS,MD

CONTACT

416-603-5800; jayanta.chowdhury@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 12, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-04

Locations

CA (1)