Accuracy Performance Verification of the INVOS™ PM7100 System in Adults

NCT ID: NCT06581835

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2025-07-22

Brief Summary

Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard

Detailed Description

The purpose of this study is to provide data for verification of the INVOS™ PM7100 System paired with the Adult Sensor (PMSENS71-A). Medtronic evaluates the performance and/or feasibility of non-invasive optical devices over a clinically relevant range of arterial saturations. This study evaluates rSO2 accuracy of tissue oximetry equipment compared directly to the actual saturation of arterial and jugular blood samples (SaO2) and (SjvO2) and the composite of the two (SavO2) as measured by co-oximetry.

Conditions

Oxygen Saturation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational

Healthy, non-smoking volunteers ages 18-50 years who meet inclusion criteria

Observational

Intervention Type: DEVICE

The study objective requires placement of a jugular venous bulb catheter in the right or left jugular venous bulb with ultrasound guidance. A venous and radial arterial line will be placed. Two INVOS™ sensors (PMSENS71-A) will be placed bilaterally on the subject's forehead. The INVOS™ device will be evaluated for a targeted range of 70-100% SpO2 levels. Hypoxic mixtures of gas are delivered, and data are collected at approximately (\~) 5-minute intervals during steady periods of increasing and decreasing oxygen concentration.

Interventions

Observational

The study objective requires placement of a jugular venous bulb catheter in the right or left jugular venous bulb with ultrasound guidance. A venous and radial arterial line will be placed. Two INVOS™ sensors (PMSENS71-A) will be placed bilaterally on the subject's forehead. The INVOS™ device will be evaluated for a targeted range of 70-100% SpO2 levels. Hypoxic mixtures of gas are delivered, and data are collected at approximately (\~) 5-minute intervals during steady periods of increasing and decreasing oxygen concentration.

Intervention Type: DEVICE

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]

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

MDT23038INSENS

Identifier Type: -

Identifier Source: org_study_id