Learning Curves of Gastric Ultrasound for Novel

Learning Curve Clinical Trial

Official title:

The Feasibility of Ultrasound for the Qualitative Assessment of Gastric Content, and Determine the Reliability of This Novel Tool in Gastric Volume Measurements When Performed by Novice Gastric Sonographers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04760106
• Other study ID #: Si 830/2018
• Status: Recruiting
• Start date: January 15, 2019
• Est. completion date: March 2021

Study information

• Verified date: February 2021
• Source: Mahidol University
• Contact: Pawinee Pangthipampai, M.D.
• Phone: +66864001721
• Email: pawinee141[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Various studies have shown that gastric sonography can reliably provide information on both qualitative (nature of content) and quantitative (volume) aspects of gastric content. A recent study has suggested that a minimum of 33 scans is needed to achieve a 95% success rate in the qualitative assessment of gastric ultrasound. However, as the risk and severity of aspiration are also influenced by gastric volume, further study concerning quantitative assessment is warranted.

Description:

This study are conducted to affirm the feasibility of ultrasound for the qualitative assessment of gastric content, and determine the reliability of this novel tool in gastric volume measurements when performed by novice gastric sonographers. Two novels in gastric ultrasound learn from online materials, including educational videos and picture library through www.gastricultrasound.org and www.usra.ca. 1-hour lecture with discussion and 1-hour interactive hands-on with expert in gastric ultrasound. Then the novels were tested for the accuracy and reliability of their skills from 50 volunteers gastric ultrasound assessment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• age between 18 to 70 years old with an American Society of Anesthesiologist physical status class I to II

Exclusion Criteria:

• BMI > 40 kg/m2; pregnancy; diabetes mellitus; a history of upper gastrointestinal tract disease (including hiatal hernia and gastric tumors); and previous surgical procedures on the esophagus, stomach, or upper abdomen.

Related Conditions & MeSH terms

• Gastric Ultrasound
• Learning Curve
• Novel in Gastric Ultrasound

Intervention

Diagnostic Test:
• gastric ultrasound
For the qualitative assessment, every participant was scanned once by both examiners. Each scan session lasted no longer than 5 minutes to mitigate the confounding effect of gastric emptying time. For the quantitative assessment, the participants were put in a right lateral decubitus position and the antral cross-sectional area (CSA) is measured in the sagittal plane.

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of qualitative ultrasound assessment of gastric content in novel gastric sonographers	Number of volunteers which novel gastric sonographers are correct to identify whether is empty, fluid or solid (percentage)	3 months
Secondary	An interrater reliability of the quantitative ultrasound assessment of the gastric volume	Using the result of cross sectional area from both novel gastric sonographers	3 months