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Acute Gastrointestinal Bleeding Peripheral Pulse Volume Changes

Peripheral Pulse Volume Changes in Acute Gastrointestinal Bleeding

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06441201
Enrollment
13
Registered
2024-06-04
Start date
2024-06-13
Completion date
2025-09-22
Last updated
2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GastroIntestinal Bleeding

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.

Interventions

DIAGNOSTIC_TESTPulse 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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in peripheral pulse volume with and without active bleedingBaseline, approximately 2 hours post endoscopyPeripheral pulse volume as measured by pulse flowmeter (uL/cm) pre and post endoscopic evaluation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026