Perfusion Index Parameter

Verification of a Perfusion Index Parameter in Adult Volunteers

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

Study Overview

• Status: Completed
• Conditions: Perfusion; Complications

Detailed Description

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 (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Medtronic Clinical Physiology Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy Male or Female volunteers age ≥18 years, weighing greater than 40kgs.

Description

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 -

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy Volunteers; Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Randall M Clark, M.D., Medtronic Clinical Physiology Lab

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Actual): September 13, 2024
• Study Completion (Actual): September 13, 2024

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 4, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MDT23025OM2VLP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No