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

6. května 2026 aktualizováno: University Health Network, Toronto

Development of an Artificial Intelligence Algorithm to Enhance the Gastric Point-of-care Ultrasound. A Proof-of-concept Study.

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)

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

30

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M5T 2S8
        • Toronto Western Hospital, University Health Network
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Anahi Perlas, MD, FRCPC

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Adult healthy volunteer aged ≥18 years

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
To see the overall accuracy of the AI model
Časové okno: Through study completion, an average of 2 years
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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
To measure the accuracy of the AI model in differentiating a empty from a full stomach
Časové okno: Through study completion, an average of 2 years
To see the accuracy of the AI-enhanced ultrasound model to differentiate an "empty" (no content or clear fluid with an antral CSA (Cross-sectional Area)< 10 cm2 in the RLD) from a "full" stomach (solid content or clear fluid with an antral CSA > 10cm2 in the RLD).
Through study completion, an average of 2 years
To measure the balanced accuracy of the AI model
Časové okno: Through study completion, an average of 2 years
Balanced accuracy accounts for uneven distributions of detected objects (e.g., small vs. large anatomical structures)
Through study completion, an average of 2 years
To measure the precision of the AI model
Časové okno: Through study completion, an average of 2 years
Precision evaluates the proportion of true positives among detected objects, addressing false positives that can lead to unnecessary interventions in clinical settings.
Through study completion, an average of 2 years
To measure the recall of the AI model
Časové okno: Through study completion, an average of 2 years
(b) Recall (sensitivity) quantifies the model's ability to detect all relevant objects (true positives), critical for avoiding missed detections (false negatives) in important medical diagnoses.
Through study completion, an average of 2 years
To evaluate the model's classification performance across different confidence thresholds.
Časové okno: Through study completion, an average of 2 years
Receiver Operating Characteristic (ROC) curves and Area Under Curve (AUC) will be computed to evaluate the model's classification performance across different confidence thresholds.
Through study completion, an average of 2 years
To evaluate the model's performance in detecting different anatomical structures (e.g., organs, vessels).
Časové okno: Through study completion, an average of 2 years
Class-specific mean Average Precision (mAP) will be calculated to evaluate the model's performance in detecting different anatomical structures (e.g., organs, vessels). mAP is the standard metric for object detection tasks, summarizing precision and recall across multiple confidence thresholds.
Through study completion, an average of 2 years
To measure the latency and average inference time per image
Časové okno: Through study completion, an average of 2 years
Given the clinical need for real-time feedback during ultrasound procedures, the average inference time per image and latency will be measured for each model.
Through study completion, an average of 2 years

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University Health Network, Toronto

Vyšetřovatelé

  • Vrchní vyšetřovatel: Anahi Perlas, University Health Network, Toronto

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

8. května 2026

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

27. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

6. května 2026

První zveřejněno (Aktuální)

12. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. května 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

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  • 25-6148

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