Acute Gastrointestinal Bleeding Peripheral Pulse Volume Changes

Peripheral Pulse Volume Changes in Acute Gastrointestinal Bleeding

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.

Study Overview

• Status: Completed
• Conditions: GastroIntestinal Bleeding
• Intervention / Treatment: Diagnostic test: Pulse flowmeter

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 Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Andrew Storm, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2024
• Primary Completion (Actual): September 22, 2025
• Study Completion (Actual): September 22, 2025

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Pathological Conditions, Signs and Symptoms; Gastrointestinal Hemorrhage
• Other Study ID Numbers: 23-005579

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No