Bedside Ultrasonic Assessment for Gastric Content in Patients With Upper GI Bleeding Undergoing Endoscopy: a Pilot Study

Point of Care Ultrasound Clinical Trial

Official title:

Bedside Ultrasonic Assessment for Gastric Content in Patients With Upper GI Bleeding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763745
• Other study ID #: 5220358
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Loma Linda University
• Contact: Yinglin Gao, DO
• Phone: 9172876166
• Email: ygao[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age >18

2. patient presents with hematemesis

3. and/or melena

4. and/or hematochezia accompanied by hemodynamic changes (pulse >100/min and/or systolic blood pressure <100/min)

5. Patient is scheduled for upper endoscopy due to the above.

Exclusion Criteria:

1. Decline consent for study

2. Patients with last solid meal <6 hours and clear liquids <2 hours prior to the endoscopy

3. Prior surgery in the stomach

4. Patient has duodenum, Ileus, or bowel obstruction

5. patient has history of gastric cancer

Related Conditions & MeSH terms

• Gastric Content
• Gastrointestinal Hemorrhage
• Hemorrhage
• Point of Care Ultrasound
• Upper Endoscopy
• Upper GI Bleeding

Intervention

Diagnostic Test:
• Point of Care Ultrasound
Use Point of Care Ultrasound to evaluate the gastric content/bleed prior to upper endoscopy

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	after obtaining informed consent and prior to endoscopy being conducted.