Validation of Next Generation Cerebral and Tissue Oximeter

Medtronic

Status: Completed

Conditions: Oxygen Deficiency

Treatments: Device: Desaturation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03128372

MDT16010MAVJB3

Details and patient eligibility

About

This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.

Enrollment: 32 patients

Sex: All

Ages: 18 to 46 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy, male or female subjects between the ages of 18 to ≤46 years;
2. Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant;
3. Minimum weight 40kg;
4. BMI within range 18.0 - 30.0.

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. Taking any medication other than birth control [self-reported];
4. Is currently participating in, or has 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];
5. Has a negative Allen's Test to confirm non-patency of the collateral artery [clinical assessment by PI or delegate];
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 female with a positive pregnancy test [serum or urine], or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breastfeeding;
8. Has anemia [lab values specific for gender];
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 [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]

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Desaturation

Experimental group

Description:

Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.

Treatment:

Device: Desaturation