Perfusion Index Parameter

Completed

• Conditions: Perfusion; Complications

• Registration Number: NCT06586918
• Lead Sponsor: Medtronic - MITG

Brief Summary

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

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 Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-04
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Primary Completion: 2024-09-13
• Study Completion: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perfusion Index (PI) correlation to doppler measurement	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.

Trial Locations

Locations (1)

Medtronic Clinical Physiology Lab; 🇺🇸 Denver, Colorado, United States