Status:
COMPLETED
Perfusion Index Parameter
Lead Sponsor:
Medtronic - MITG
Conditions:
Perfusion; Complications
Eligibility:
All Genders
18+ years
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 wit...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 -
Key Trial Info
Start Date :
September 4 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 13 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06586918
Start Date
September 4 2024
End Date
September 13 2024
Last Update
October 26 2024
Active Locations (1)
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1
Medtronic Clinical Physiology Lab
Denver, Colorado, United States, 80218