Perfusion Index Parameter

Medtronic - MITG32 enrolled

Overview

To evaluate the association between the Perfusion index parameter and an independent measure of perfusion.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Perfusion; Complications

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects ≥18 years of age 2. Subject is able to participate for the duration of the study 3. Subject is willing to sign an informed consent 4. Subject weighs \>40kg Exclusion Criteria: 1. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect the ability to test sensors 2. Physiologic abnormalities that prevent proper application of pulse oximetry sensor 3. Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes. 4. Raynaud Syndrome 5. Repeated systolic blood pressure \> 140mmHg -

Locations (1)

Medtronic Clinical Physiology Lab

Denver, Colorado, United States

Outcomes

Primary Outcomes

Perfusion Index (PI) correlation to doppler measurement

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.

Time frame: 1 hour

Data from ClinicalTrials.gov

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