Accuracy Verification of the INVOS PM7100

Medtronic

Status

Active, not recruiting

Conditions

Tissue Oxygenation

Treatments

Device: Observational

Study type

Observational

Funder types

Industry

Identifiers

NCT07166341

MDT24046IN4WVL

Details and patient eligibility

About

Prospective, observational, pre-market, verification study to confirm accuracy of the INVOS 7100 system in compliance with ISO 80601-2-85:2021 standard

Full description

Verify that the INVOS PM7100 system in conjunction with the INVOS Adult Sensors meets the requirements for tissue saturation accuracy.

Enrollment

48 patients

Sex

All

Ages

18 to 46 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subjects between the ages of ≥18 to <47 years
Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant
Subject is a non-smoker or has not smoked within 2 days prior to the study
Minimum weight 40kg
BMI within range 18.0-- 35.0
Reference tissue hemoglobin oxygen saturation over the range 50% to 85%

Exclusion criteria

Compromised circulation, injury, or physical malformation of fingers, hands, or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized)
Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) [self-reported]
Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported]
Subjects taking certain medication(s) beyond birth control may be excluded from participating at the PI discretion [self-reported]
Subject participation will be at the PI's discretion if they are currently participating in, or if they have recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study [self-reported]
Negative Allen's test for radial and ulnar patency
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]
Individuals of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study and is unwilling to use effective birth control between the time of screening and study procedure, or is breastfeeding.
Has anemia [lab values specific for gender]
Has a history of sickle cell trait or thalassemia [self-reported]
Has an abnormal hemoglobin electrophoresis test [lab measurement]
Has a positive urine cotinine test or urine drug screen or oral ethanol test [Point of Care (POC) testing]
Has a room air saturation less than 95% by pulse oximetry [measurement by PI or delegate]
Has a clinically significant abnormal ECG [assessment by PI or delegate]
Has a clinically significant abnormal pulmonary function test via spirometry [assessment by PI or delegate]
Has a COHb greater than 3%, or MetHb greater than 2% [measured by venous blood sample co-oximetry]
Has tHb < 10 g/dl as assessed by co-oximetry during the procedure