Learning Curves of Gastric Ultrasound for Novel
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
1 other identifier
observational
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2019
CompletedFirst Submitted
Initial submission to the registry
February 7, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedFebruary 18, 2021
February 1, 2021
2.1 years
February 7, 2021
February 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
An interrater reliability of the quantitative ultrasound assessment of the gastric volume
3 months
Interventions
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.
Eligibility Criteria
Fifty healthy volunteers
You may qualify if:
- age between 18 to 70 years old with an American Society of Anesthesiologist physical status class I to II
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Siriraj hospital
Bangkok, 10700, Thailand
Related Publications (1)
Tankul R, Halilamien P, Tangwiwat S, Dejarkom S, Pangthipampai P. Qualitative and quantitative gastric ultrasound assessment in highly skilled regional anesthesiologists. BMC Anesthesiol. 2022 Jan 3;22(1):5. doi: 10.1186/s12871-021-01550-z.
PMID: 34979932DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Pawinee Pangthipampai, M.D.
Siriraj Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2021
First Posted
February 18, 2021
Study Start
January 15, 2019
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
February 18, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share