AI for Gastric POCUS ( Point-of-care Ultrasound)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Point-of-care Ultrasound. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of an Artificial Intelligence Algorithm to Enhance the Gastric Point-of-care Ultrasound. A Proof-of-concept Study.
Overview
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)
Detailed description
Gastric (stomach) Point-of-care ultrasound (POCUS) is an ultrasound examination done at bedside to assess the stomach. It is a validated non-invasive way to find out what is the content in the stomach and its volume. Gastric POCUS is increasingly used before surgery to determine the risk of gastric contents going into the lungs (possibly causing a lung infection and breathing problems) and guide anesthetic management whenever the doctors are not certain about the stomach content based on clinical information.
Gastric POCUS is a relatively new skill for anesthesiologists. While, obtaining the required images is relatively straightforward, the interpretation of such images, however, requires advanced training. Preliminary data have suggested that Artificial Intelligence (AI)-based programs and devices can help in image capturing and its interpretation for other ultrasound applications. This study will be the first to the researcher's knowledge to develop an AI algorithm to enhance anesthesiologists' ability to recognize a full stomach using gastric POCUS. 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.
This is an observational prospective cohort study that follows the CONSORT (Consolidated Standards of Reporting Trials)-AI extension reporting guidelines.
The researchers expect to enroll 30 healthy volunteers for the study.
Following a period of fasting for solids for at least 8 hours and clear fluids for at least 2 hours from the time of study visit. An anesthesiologist or sonographer with a minimum previous experience of 50 gastric ultrasound examinations will perform a standardized gastric ultrasound exam.
A baseline ultrasound examination will be conducted first with the participant lying on their back with the head elevated at 30 degrees (supine position) and then again with the participant lying on their right side (right lateral decubitus position(RLD)).
The same procedure will be repeated twice after ingestion of
1. various volumes of water (100-500) determined at random 2. 1 of 5 different solid or thick fluid foods also determined at random (a banana, an apple, a cup of yogurt, a croissant or a muffin).
Each one of the 30 participants will be randomized to 1 of 5 different volumes of water (100ml, 200ml, 300ml, 400ml, 500ml). Then ultrasound images will be obtained. Subsequently, each participant will also be randomized to 1 of 5 solids (a banana, an apple, a cup of yogurt, a croissant or a muffin) in a 1:1:1:1:1 ratio. A computer-generated list of random numbers for each participant will be created.
The investigators plan to collect 90 10-second clips in total, and each clip can be deconstructed into 10 frozen frames per second, for a total of 100 frozen frames per clip. The investigators expect to generate 9,000 individual images, 80% of which will be used to train the model, 10% to fine-tune and 10% to test the model accuracy. The three de-identified clips from each participant will be normalized and annotated by consultant anesthesiologists to indicate orientation (medial or lateral, cephalad or caudad) and identify relevant structures, as well as the type of content and antral CSA in the right lateral decubitus in case of fluid.
All the collected images will then be fed to an AI to generate computational data.
Primary outcome measures
- To see the overall accuracy of the AI model [Time frame: Through study completion, an average of 2 years]
Secondary outcome measures (7)
- To measure the accuracy of the AI model in differentiating a empty from a full stomach [Time frame: Through study completion, an average of 2 years]
- To measure the balanced accuracy of the AI model [Time frame: Through study completion, an average of 2 years]
- To measure the precision of the AI model [Time frame: Through study completion, an average of 2 years]
- To measure the recall of the AI model [Time frame: Through study completion, an average of 2 years]
- To evaluate the model's classification performance across different confidence thresholds. [Time frame: Through study completion, an average of 2 years]
- To evaluate the model's performance in detecting different anatomical structures (e.g., organs, vessels). [Time frame: Through study completion, an average of 2 years]
- To measure the latency and average inference time per image [Time frame: Through study completion, an average of 2 years]
Eligibility criteria
Inclusion criteria
A. Inclusion Criteria at the level of the participants
- Participants must meet all the following inclusion criteria to be eligible for the study:
- Aged ≥18 years
- Any sex
- Be healthy
B. Inclusion Criteria at the level of the input data • Transverse ultrasound images (10 sec clips) of the gastric antrum in the epigastric area that contain all these structures:
- The edge of the left lobe of the liver
- The gastric antrum
- The pancreas
- The aorta
Exclusion criteria
A. Exclusion Criteria at the level of the participants
- Participants meeting any of the following exclusion criteria are ineligible for the study:
- Previous gastro-esophageal surgery (e.g., gastric by-pass, sleeve gastrectomy, fundoplication, partial gastrectomy)
- Allergy to any of the food that will be provided.
B. Exclusion Criteria at the level of the input data
- Ultrasound images (10 sec clips) where the gastric antrum cannot be positively identified.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Toronto Western Hospital, University Health Network — Toronto
Identifiers
NCT: NCT07580456 · 25-6148