Clinical trial NCT06581835: Accuracy Performance Verification of the INVOS™ PM7100 System in Adults
Official title: Accuracy Performance Verification of the INVOS™ PM7100 System by Comparing rSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oxygen Saturation
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2024-09-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, non-smoking volunteers ages 18-50 years who meet inclusion criteria

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.

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% \[measured by venous blood sample co-oximetry\]

Primary outcomes:
measure: Accuracy root mean square
timeFrame: rSO2 and fSO2 data are recorded every 5-minutes during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References: