Ultrasound Evaluation of Gastric ContentsNCT05469633
Application of Portable Ultrasonic Evaluation of Gastric Contents in Painless Gastroscopy
An observational study of Ultrasound Evaluation of Gastric Contents, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Evaluation of Gastric Contents
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2022to 31 Jul 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients undergoing painless electronic gastroscopy were fasted for 8 hours in acccordance with gastroscopy guidelines
Who may be able to join
- ≥18years
- Patients undergoing painless electronic gastroscopy.
- Voluntarily participate and sign informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
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.
- Keywords
- gastric ultrasound, gastric contents, painless electronic gastroscope
What is being measured
The primary outcome is the main question the study is designed to answer.
The cross-sectional area of the antrum (CSA)
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
Measured: Before the painless electronic gastroscopy
Predicted volume
Predicted volume calculated by CSA
Measured: Before the painless electronic gastroscopy
Observed volume
All gastric fluid was thoroughly suctioned through an endoscope side port, measured to the nearest mL and recorded
Measured: Before the painless electronic gastroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start29 Aug 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Evaluation of Gastric ContentsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Yupei, Study director, Department of Anesthesiology,The Second Affiliated Hospital ,Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469633
- Sponsor's protocol ID
- ultrasound and contents
- Status last verified
- Sep 2022
- First submitted
- 20 Jul 2022
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Portable Ultrasonic Evaluation of Gastric Contents in Painless Gastroscopy
- ClinicalTrials.gov ID
- NCT05469633
- Acronym / sponsor ID
- ultrasound and contents
- Keywords
- gastric ultrasound, gastric contents, painless electronic gastroscope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 22 Jul 2022 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients undergoing painless electronic gastroscopy were fasted for 8 hours in acccordance with gastroscopy guidelines
Key inclusion criteria (3 listed)
- ≥18years
- Patients undergoing painless electronic gastroscopy.
- Voluntarily participate and sign informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Predicted volume
Time frame: Before the painless electronic gastroscopy
Predicted volume calculated by CSA
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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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.
Chen Yupei study director
Department of Anesthesiology,The Second Affiliated Hospital ,Chongqing Medical University
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 Ultrasound Evaluation of Gastric Contents, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Aug 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cross-sectional area of the antrum (CSA) (time frame: Before the painless electronic gastroscopy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2024.