Gastric UltrasoundNCT04760106
Learning Curves of Gastric Ultrasound for Novel
An observational study of Gastric Ultrasound and Learning Curve, run by Mahidol University at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Ultrasound, Learning Curve, Novel in Gastric Ultrasound
- What is being tested?
- gastric ultrasound
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 15 Jan 2019to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Fifty healthy volunteers
Who may be able to join
- age between 18 to 70 years old with an American Society of Anesthesiologist physical status class I to II
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj hospital
Bangkok, 10700
Pawinee Pangthipampai, M.D., 66864001721, pawinee141@gmail.com
Pawinee Pangthipampai, M.D.
About this study
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
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.
Read the 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.
- Being tested
- gastric ultrasound
- Keywords
- Gastric ultrasound, Learning curve, Accuracy, Reliability, Novel in gastric ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric ultrasoundDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (1)
An interrater reliability of the quantitative ultrasound assessment of the gastric volume
Using the result of cross sectional area from both novel gastric sonographers
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start15 Jan 2019
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric UltrasoundStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pawinee Pangthipampai, M.D., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760106
- Sponsor's protocol ID
- Si 830/2018
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34979932
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04760106
- Acronym / sponsor ID
- Si 830/2018
- Keywords
- Gastric ultrasound, Learning curve, Accuracy, Reliability, Novel in gastric ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Fifty healthy volunteers
Key inclusion criteria (1 listed)
- age between 18 to 70 years old with an American Society of Anesthesiologist physical status class I to II
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastric ultrasoundFor 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. | Diagnostic test | – |
Primary outcome
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)
1 secondary outcome
An interrater reliability of the quantitative ultrasound assessment of the gastric volume
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 34979932Tankul 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pawinee Pangthipampai, M.D. principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Ultrasound and Learning Curve, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pawinee Pangthipampai, M.D. (+66864001721, pawinee141@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of qualitative ultrasound assessment of gastric content in novel gastric sonographers (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04760106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.