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NCT06441201 Clinical Trial

Acute Gastrointestinal Bleeding Peripheral Pulse Volume Changes

GastroIntestinal Bleeding Clinical Trial

Official title:
Peripheral Pulse Volume Changes in Acute Gastrointestinal Bleeding

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06441201
Other study ID # 23-005579
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 13, 2024
Est. completion date August 2024

Study information
Verified date June 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 10
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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