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

Sponsor
Loma Linda University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05763745
Collaborator
(none)
50
1
1
10.7
4.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Point of Care Ultrasound
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Bedside Ultrasonic Assessment for Gastric Content in Patients With Upper GI Bleeding
Actual Study Start Date :
Feb 10, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. measurement is gastric food content/blood. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loma Linda University Medical Center Loma Linda California United States 92354

Sponsors and Collaborators

  • Loma Linda University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John Jae-Woo Kim, John Jae-woo Kim M.D., Loma Linda University
ClinicalTrials.gov Identifier:
NCT05763745
Other Study ID Numbers:
  • 5220358
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2023