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

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.

Study Overview

• Status: Recruiting
• Conditions: Point of Care Ultrasound; Upper GI Bleeding; Gastric Content; Upper Endoscopy; GI Bleed
• Intervention / Treatment: Diagnostic test: Point of Care Ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yinglin Gao, DO; Phone Number: 9172876166; Email: ygao@llu.edu
• Study Contact Backup: Name: John Jae-Woo Kim, MD; Email: johnjkim@llu.edu

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Loma Linda University Medical Center
      • Contact: Yinglin Gao, D.O.; Phone Number: 917-287-6166; Email: ygao@llu.edu
      • Contact: John Jae-Woo Kim, M.D.; Email: JohnJKim@llu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Point of Care Ultrasound	Diagnostic test: Point of Care Ultrasound; Use Point of Care Ultrasound to evaluate the gastric content/bleed prior to upper endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: 5220358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes