Hand Perfusion and Pulse Oximetry Performance

Not yet recruiting

• Conditions: Oxygen Saturation

• Registration Number: NCT06925646
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to compare oxygen saturation measurement readings from manufactured pulse oximetry devices to the oxygen saturation measurements of arterial blood samples drawn at the same time of measurements.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-13
• Study Start: 2025-05-01
• Primary Completion: 2027-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy adult men and women of all races and ethnic backgrounds recruited from faculty and staff of the Mayo Medical Center and from Rochester, MN and surrounding communities.
• Equal number of male and female participants to address potential sex differences in physiology.
• We will intentionally recruit subjects with dark skin because of the issues surrounding accuracy of pulse oximetry and skin tone.
• Non-smokers
• BMIs between 18-30 kg·m-2.
• Female subjects will be non-pregnant.
• Free of cardiopulmonary diseases or other conditions and/or taking medications that might affect pulse oximeter-based estimates of arterial saturation.
• All inclusion and exclusion criteria are at the discretion of the Principal Investigator.
• At least 8 of the subjects will have Fitzpatrick Skin Type of IV to VI.

Exclusion Criteria

• Children under the age of 18 will not be studied. We will exclude children less than 18 years of age because they are unable to give consent, and because these studies are non-therapeutic.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial oxygen saturation measured via arterial blood gas sample (Sa02)	30 minutes, 90 minutes, 3 hours	Arterial oxygen saturation will be obtained via a blood sample at the end of each stage of the breath down protocols and is reported as a percentage.
Arterial oxygen saturation measured via pulse oximeters (Sp02)	30 minutes, 90 minutes, 3 hours	Arterial oxygen saturation will be obtained via pulse oximeter reading at the end of each stage of the breath down protocols and is reported as a percentage.

Trial Locations

Locations (1)

Mayo Clinic Department of Anesthesiology; 🇺🇸 Rochester, Minnesota, United States