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

Primary Purpose

Upper GI Bleeding, Point of Care Ultrasound, Upper Endoscopy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point of Care Ultrasound
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Upper GI Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Loma Linda University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Point of Care Ultrasound

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2023
Last Updated
February 28, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT05763745
Brief Title
Bedside Ultrasonic Assessment for Gastric Content in Patients With Upper GI Bleeding Undergoing Endoscopy: a Pilot Study
Official Title
Bedside Ultrasonic Assessment for Gastric Content in Patients With Upper GI Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper GI Bleeding, Point of Care Ultrasound, Upper Endoscopy, Gastric Content, GI Bleed

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Point of Care Ultrasound
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Point of Care Ultrasound
Intervention Description
Use Point of Care Ultrasound to evaluate the gastric content/bleed prior to upper endoscopy
Primary Outcome Measure Information:
Title
measurement is gastric food content/blood.
Description
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.
Time Frame
after obtaining informed consent and prior to endoscopy being conducted.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yinglin Gao, DO
Phone
9172876166
Email
ygao@llu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John Jae-Woo Kim, MD
Email
johnjkim@llu.edu
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yinglin Gao, D.O.
Phone
917-287-6166
Email
ygao@llu.edu
First Name & Middle Initial & Last Name & Degree
John Jae-Woo Kim, M.D.
Email
JohnJKim@llu.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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