Upper GI BleedingNCT05763745
Bedside Ultrasonic Assessment for Gastric Content in Patients With Upper GI Bleeding Undergoing Endoscopy
An observational study of Upper GI Bleeding and Point of Care Ultrasound, run by Loma Linda University at 1 site in United States.
Trial summary
Emerging studies have evaluated POCUS (Point of Care Ultrasound) for assessing of gastric content prior to anesthesia to reduce the risk of aspiration and demonstrated that POCUS can accurately identify presence of gastric food or fluid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper GI Bleeding, Point of Care Ultrasound, Upper Endoscopy
- What is being tested?
- Point of Care Ultrasound
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2023to 3 Apr 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Age >18 admitted with upper GI bleeding defined by symptoms of hematemesis, melena, and/or hematochezia accompanied by hemodynamic changes (pulse >100/min and/or systolic blood pressure <100/min) scheduled for upper endoscopy.
Who may be able to join
- Age >18
- patient presents with hematemesis
- and/or melena
- and/or hematochezia accompanied by hemodynamic changes (pulse >100/min and/or systolic blood pressure <100/min)
- Patient is scheduled for upper endoscopy due to the above.
Who cannot join
- Decline consent for study
- Patients with last solid meal <6 hours and clear liquids <2 hours prior to the endoscopy
- Prior surgery in the stomach
- Patient has duodenum, Ileus, or bowel obstruction
- patient has history of gastric cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: Bedside Ultrasonic Assessment for Gastric Content in Patients With Upper GI Bleeding
Emerging studies have evaluated POCUS (Point of Care Ultrasound) for assessing of gastric content prior to anesthesia to reduce the risk of aspiration and demonstrated that POCUS can accurately identify presence of gastric food or fluid. Despite accumulating studies evaluating POCUS as a diagnostic modality to evaluate for gastric food content prior to anesthesia, there is no study to date that has evaluated the role of POCUS prior to endoscopy among patients with upper GI bleeding. Therefore, this study is to evaluate the diagnostic accuracy of POCUS for retained gastric content prior to endoscopy among patient hospitalized/admitted with upper GI bleeding. This study would take place at Loma Linda University Medical Center. Subjects will be any one who has upper GI bleed required EGD and age of greater than 18 years old. The study will plan for 1 year or reach 50 patients (whichever one comes first). In addition, subjects will be recruited from ED, ICU, Medicine ward by the PI, SubPI, and Collaborators. Subject will received ultrasound up to 6 hours prior the start of endoscopy. The location of Ultrasound would either take place at GI lab prior to scope or at the ward prior to transportation to GI lab or at ICU prior to endoscopy. The ultrasound would focus upper abdomen area and look for antrum. the result will be immediately read before endoscopy and fill out on the sheet before the endoscopy. Patient then proceed with endoscopy. At the end of the scope, the researcher will ask the endoscopist questions regarding how well they could see each part of the stomach in order to complete the study. Both results are compared between US and Endoscopy. Endoscopist is blinded in this study.
- Being tested
- Point of Care Ultrasound
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care UltrasoundDiagnostic test
Use Point of Care Ultrasound to evaluate the gastric content/bleed prior to upper endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Point of Care Ultrasound | Not described Receives: Diagnostic Test: Point of Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement is gastric food content/blood.
Ultrasound would be conducted on upper abdomen to evaluate the presence of blood and/or food in the stomach. The result would divided into empty (no food), small and large. ultrasound mainly evaluate the antrum area to see whether it is dilated/distended or not. if it is collapsed, then it is considered empty. If it is largely dilated, it would be considered large.
Measured: after obtaining informed consent and prior to endoscopy being conducted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start10 Feb 2023
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper GI BleedingStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763745
- Sponsor's protocol ID
- 5220358
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Ultrasonic Assessment for Gastric Content in Patients With Upper GI Bleeding
- ClinicalTrials.gov ID
- NCT05763745
- Acronym / sponsor ID
- 5220358
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 10 Mar 2023 (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.
Emerging studies have evaluated POCUS (Point of Care Ultrasound) for assessing of gastric content prior to anesthesia to reduce the risk of aspiration and demonstrated that POCUS can accurately identify presence of gastric food or fluid. Despite accumulating studies evaluating POCUS as a diagnostic modality to evaluate for gastric food content prior to anesthesia, there is no study to date that has evaluated the role of POCUS prior to endoscopy among patients with upper GI bleeding. Therefore, this study is to evaluate the diagnostic accuracy of POCUS for retained gastric content prior to endoscopy among patient hospitalized/admitted with upper GI bleeding. This study would take place at Loma Linda University Medical Center. Subjects will be any one who has upper GI bleed required EGD and age of greater than 18 years old. The study will plan for 1 year or reach 50 patients (whichever one comes first). In addition, subjects will be recruited from ED, ICU, Medicine ward by the PI, SubPI, and Collaborators. Subject will received ultrasound up to 6 hours prior the start of endoscopy. The location of Ultrasound would either take place at GI lab prior to scope or at the ward prior to transportation to GI lab or at ICU prior to endoscopy. The ultrasound would focus upper abdomen area and look for antrum. the result will be immediately read before endoscopy and fill out on the sheet before the endoscopy. Patient then proceed with endoscopy. At the end of the scope, the researcher will ask the endoscopist questions regarding how well they could see each part of the stomach in order to complete the study. Both results are compared between US and Endoscopy. Endoscopist is blinded in this study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Point of Care Ultrasound | – | Diagnostic Test: Point of Care Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age >18 admitted with upper GI bleeding defined by symptoms of hematemesis, melena, and/or hematochezia accompanied by hemodynamic changes (pulse >100/min and/or systolic blood pressure <100/min) scheduled for upper endoscopy.
Key inclusion criteria (5 listed)
- Age >18
- patient presents with hematemesis
- and/or melena
- and/or hematochezia accompanied by hemodynamic changes (pulse >100/min and/or systolic blood pressure <100/min)
- Patient is scheduled for upper endoscopy due to the above.
Key exclusion criteria (5 listed)
- Decline consent for study
- Patients with last solid meal <6 hours and clear liquids <2 hours prior to the endoscopy
- Prior surgery in the stomach
- Patient has duodenum, Ileus, or bowel obstruction
- patient has history of gastric cancer
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 |
|---|---|---|
| Point of Care UltrasoundUse Point of Care Ultrasound to evaluate the gastric content/bleed prior to upper endoscopy | Diagnostic test | Point of Care Ultrasound |
Primary outcome
measurement is gastric food content/blood.
Time frame: after obtaining informed consent and prior to endoscopy being conducted.
Ultrasound would be conducted on upper abdomen to evaluate the presence of blood and/or food in the stomach. The result would divided into empty (no food), small and large. ultrasound mainly evaluate the antrum area to see whether it is dilated/distended or not. if it is collapsed, then it is considered empty. If it is largely dilated, it would be considered large.
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 8 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Upper GI Bleeding and Point of Care Ultrasound, run by Loma Linda University at 1 site in United States.
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 5 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 8 Apr 2025. 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 United States. 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?
measurement is gastric food content/blood. (time frame: after obtaining informed consent and prior to endoscopy being conducted.). 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 8 Apr 2025.