Evaluating the accuracy of the INVOS™ PM7100 System for measuring oxygen levels in adults

Accuracy Performance Verification of the INVOS™ PM7100 System by Comparing rSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers

This study is testing how accurately the INVOS™ PM7100 System measures oxygen levels in adults aged 18 to 50 compared to traditional blood tests.

Quick facts

• Study type: Observational
• Enrollment: 38 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Medtronic - MITG (Industry-sponsored)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT06581835 on ClinicalTrials.gov

What this trial studies

This observational study aims to verify the accuracy of the INVOS™ PM7100 System when used with the Adult Sensor in adults aged 18 to 50. Participants will undergo health screenings and have their arterial and jugular blood oxygen saturation levels measured to compare with the readings from the non-invasive optical device. The study is designed to ensure compliance with the ISO 80601-2-85:2021 standard, focusing on the performance of the device across a clinically relevant range of oxygen saturation levels. Data collected will help assess the feasibility and accuracy of this tissue oximetry equipment.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 50 with a BMI between 18.0 and 29.9.

Not a fit: Patients with known allergies to lidocaine or medical adhesives, or those with certain medical conditions such as anemia, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the reliability of non-invasive oxygen saturation monitoring in clinical settings.

How similar studies have performed: While this study focuses on a specific device, similar observational studies have shown success in verifying the accuracy of non-invasive monitoring technologies.

Eligibility criteria

Inclusion Criteria:

1. Subjects between the ages of 18 to 50 years
2. Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant
3. Minimum weight 40kg
4. BMI within range 18.0 - 29.9

Exclusion Criteria:

1. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self-reported\]
2. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\]
3. Subjects taking medication(s) beyond birth control may be excluded from participating at the PI discretion \[self-reported\]
4. Any interventional study within 30 days that, in the opinion of the PI, electrocardiogram (ECG) may interfere with study participation (i.e., drug, biologic)
5. Negative Allen's test for radial and ulnar patency
6. Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\]
7. Is pregnant
8. Has anemia as measured by co-oximetry \[values specific for sex\]
9. Has a history of sickle cell trait or thalassemia \[self-reported\]
10. Has an abnormal hemoglobin electrophoresis test \[lab measurement\]
11. Has a positive urine cotinine test or urine drug screen or oral ethanol test \[Point of Care (POC) testing\]
12. Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\]
13. Has a clinically significant abnormal ECG \[assessment by PI or delegate\]
14. Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\]
15. Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co-oximetry\]

Where this trial is running

Durham, North Carolina

• Duke University — Durham, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Monika Deshpande

Conditions Oxygen Saturation