Perfusion Index Parameter

Medtronic

Status: Completed

Conditions: Perfusion; Complications

Study type: Observational

Funder types: Industry

Identifiers

NCT06586918

MDT23025OM2VLP

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

32 participants in 1 patient group

Healthy Volunteers