Acute Gastrointestinal Bleeding Peripheral Pulse Volume Changes

NCT ID: NCT06441201

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-13

Study Completion Date

2025-09-22

Brief Summary

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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

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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.

Conditions

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GastroIntestinal Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Pulse flowmeter

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jad P. AbiMansour

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Storm, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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23-005579

Identifier Type: -

Identifier Source: org_study_id

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