Perfusion Index Parameter | Clinical Trial

Key information

Conditions

Perfusion; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medtronic Clinical Physiology Lab

Denver, Colorado, 80218, United States

About this study

Perfusion index parameters measured with an Investigational Pulse Oximetry PCBA, paired with Market Released sensors, will be compared to perfusion levels measured by a FDA-cleared device equipped with a laser Doppler technology-based device for blood perfusion measurements. Continuous Perfusion index measurements will be taken during the test sequence.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Subjects ≥18 years of age
Subject is able to participate for the duration of the study
Subject is willing to sign an informed consent
Subject weighs >40kg

Exclusion criteria

Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect the ability to test sensors
Physiologic abnormalities that prevent proper application of pulse oximetry sensor
Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes.
Raynaud Syndrome
Repeated systolic blood pressure > 140mmHg -

Treatment and study plan

Primary outcomes

Perfusion Index (PI) correlation to doppler measurement

Time frame: 1 hour

To confirm correlation of Perfusion Index measured by the investigational pulse oximeter PCBA and Market Released sensors to the laser doppler measure of skin perfusion (LDSP) as determined by an overall instantaneous (lag(0)) Spearman rank correlation.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

Verification of a Perfusion Index Parameter in Adult Volunteers

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Sep 19, 2024
Registry last updated: May 15, 2026

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.

Published trials that share one or more normalized conditions with this study.

Completed