Acute Gastrointestinal Bleeding Peripheral Pulse Volume Changes

NCT06441201 | Completed

• 1 other identifier: 23-005579
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose and aim of this study are to compare changes in pulse volume to non-invasively predict active bleeding or high-risk stigmata in patients undergoing a gastrointestinal endoscopy to assess feasibility of the flow meter clinically.

Conditions

GastroIntestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• Changes in peripheral pulse volume with and without active bleeding

  Peripheral pulse volume as measured by pulse flowmeter (uL/cm) pre and post endoscopic evaluation

  Baseline, approximately 2 hours post endoscopy

Study Arms (1)

Gastrointestinal Bleeding Peripheral Pulse Volume

Subject undergoing an emergency endoscopic evaluation for active gastrointestinal bleeding will have their peripheral pulse volumes monitored using a pulse flowmeter throughout the procedure and 2 hours after the procedure.

Diagnostic Test: Pulse flowmeter

Interventions

Pulse flowmeter DIAGNOSTIC_TEST

Measures peripheral pulse volumes by an electrode applied non-invasively to the lower extremity (left or right) at the beginning of the endoscopic evaluation for the duration of the procedure, and up to 2 hours after the completion of the procedure.

Gastrointestinal Bleeding Peripheral Pulse Volume

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing emergent endoscopic evaluation for active gastrointestinal bleeding at Mayo Clinic, Rochester, Minnesota.

You may qualify if:

• \- Adults (age \>18yr) undergoing emergent endoscopy for active GI bleeding.

You may not qualify if:

• Patients with pre-existing heart failure (ejection fraction \<40%), cardiac rhythm abnormalities and peripheral vascular disease.
• Patients with underlying implanted cardiac electrical devices and spinal cord stimulators.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Storm, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: June 13, 2024
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)