Perfusion Index Parameter

NCT06586918 | Completed

• 1 other identifier: MDT23025OM2VLP
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Perfusion; Complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Subjects ≥18 years of age
• Subject is able to participate for the duration of the study
• Subject is willing to sign an informed consent
• Subject weighs \>40kg

You may not qualify if:

• Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect the ability to test sensors
• Physiologic abnormalities that prevent proper application of pulse oximetry sensor
• Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes.
• Raynaud Syndrome
• Repeated systolic blood pressure \> 140mmHg -

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Medtronic Clinical Physiology Lab

Denver, Colorado, 80218, United States

Location

Study Officials

• Randall M Clark, M.D.

  Medtronic Clinical Physiology Lab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 4, 2024
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)