- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05469633
Application of Portable Ultrasonic Evaluation of Gastric Contents in Painless Gastroscopy
August 13, 2024 updated by: The Second Affiliated Hospital of Chongqing Medical University
To explore the correlation between gastric ultrasound evaluation and gastroscopic direct vision evaluation of gastric contents, so as to more accurately use gastric ultrasound to evaluate the gastric contents of patients undergoing painless electronic gastroscopy in the outpatient department, so as to develop an individual painless diagnosis and treatment strategy to reduce the risk of lung aspiration.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Chongqing
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Chongqing, Chongqing, China, 400010
- The Second Affiliated Hospital, Chongqing Medical University
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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
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Outpatients undergoing painless electronic gastroscopy were fasted for 8 hours in acccordance with gastroscopy guidelines
Description
Inclusion Criteria:
- ≥18years
- Patients undergoing painless electronic gastroscopy.
- Voluntarily participate and sign informed consent.
Exclusion Criteria:
- Patients undergoing general electronic gastroscopy.
- Patients who refused to undergo gastric ultrasound.
- Patients with postural difficulties during gastric ultrasonography.
- with fresh wounds or infections at the site of Gastric ultrasound
- Patients whose ultrsound image quality is too poor to properly display the relevant anatomical structures.
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: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The cross-sectional area of the antrum (CSA)
Time Frame: Before the painless electronic gastroscopy
|
The maximum anteroposterior diameter (recorded as D1) and maximum craniocaudal diameter (recorded as D2) between the gastric antrum serosal surfaces were measured perpendicularly to each other.CSA(cm2) = (π × D1 × D2) / 4
|
Before the painless electronic gastroscopy
|
|
Predicted volume
Time Frame: Before the painless electronic gastroscopy
|
Predicted volume calculated by CSA
|
Before the painless electronic gastroscopy
|
|
Observed volume
Time Frame: Before the painless electronic gastroscopy
|
All gastric fluid was thoroughly suctioned through an endoscope side port, measured to the nearest mL and recorded
|
Before the painless electronic gastroscopy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Chen Yupei, Department of Anesthesiology,The Second Affiliated Hospital ,Chongqing Medical University
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)
August 29, 2022
Primary Completion (Actual)
July 31, 2023
Study Completion (Actual)
July 31, 2023
Study Registration Dates
First Submitted
July 20, 2022
First Submitted That Met QC Criteria
July 20, 2022
First Posted (Actual)
July 22, 2022
Study Record Updates
Last Update Posted (Actual)
August 14, 2024
Last Update Submitted That Met QC Criteria
August 13, 2024
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- ultrasound and contents
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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