- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04760106
Learning Curves of Gastric Ultrasound for Novel
February 15, 2021 updated by: Mahidol University
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
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pawinee Pangthipampai, M.D.
- Phone Number: +66864001721
- Email: pawinee141@gmail.com
Study Locations
-
-
-
Bangkok, Thailand, 10700
- Recruiting
- Siriraj Hospital
-
Contact:
- Pawinee Pangthipampai, M.D.
- Phone Number: 66864001721
- Email: pawinee141@gmail.com
-
Principal Investigator:
- Pawinee Pangthipampai, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Fifty healthy volunteers
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The accuracy of qualitative ultrasound assessment of gastric content in novel gastric sonographers
Time Frame: 3 months
|
Number of volunteers which novel gastric sonographers are correct to identify whether is empty, fluid or solid (percentage)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
An interrater reliability of the quantitative ultrasound assessment of the gastric volume
Time Frame: 3 months
|
Using the result of cross sectional area from both novel gastric sonographers
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pawinee Pangthipampai, M.D., Siriraj Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2019
Primary Completion (Anticipated)
March 1, 2021
Study Completion (Anticipated)
March 1, 2021
Study Registration Dates
First Submitted
February 7, 2021
First Submitted That Met QC Criteria
February 15, 2021
First Posted (Actual)
February 18, 2021
Study Record Updates
Last Update Posted (Actual)
February 18, 2021
Last Update Submitted That Met QC Criteria
February 15, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Si 830/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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