Perfusion Index Parameter

Verification of a Perfusion Index Parameter in Adult Volunteers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06586918

Enrollment

Registered

2024-09-19

Start date

2024-09-04

Completion date

2024-09-13

Last updated

2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perfusion; Complications

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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 -

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRandall M Clark, M.D.

Medtronic Clinical Physiology Lab

Outcome results