Acute Gastrointestinal Bleeding Peripheral Pulse Volume Changes

• Conditions: GastroIntestinal Bleeding
• Interventions: Diagnostic Test: Pulse flowmeter

• Registration Number: NCT06441201
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

The maximum change in volume of a limb segment during the cardiac cycle - pulse volume - will be monitored non-invasively along with standard vitals in patients with a suspected gastrointestinal bleed undergoing endoscopy. Pulse volume and vitals will be collected prior to and following endoscopy up to the point of dismissal from the endoscopy unit so that the data may be correlated with the endoscopic and clinical findings.

Study Timeline

• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-06-04
• Study Start: 2024-06-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastrointestinal Bleeding Peripheral Pulse Volume	Pulse flowmeter	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.

Primary Outcome Measures

Name	Time	Method
Changes in peripheral pulse volume with and without active bleeding	Baseline, approximately 2 hours post endoscopy	Peripheral pulse volume as measured by pulse flowmeter (uL/cm) pre and post endoscopic evaluation

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States