Acute Gastrointestinal Bleeding Peripheral Pulse Volume Changes

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.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Changes in peripheral pulse volume with and without active bleeding

Time frame: Baseline, approximately 2 hours post endoscopy

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Peripheral Pulse Volume Changes in Acute Gastrointestinal Bleeding

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jun 4, 2024
Registry last updated: Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed