Validation of Next Generation Cerebral and Tissue Oximeter

NCT ID: NCT03128372

Last Updated: 2018-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2017-07-19

Brief Summary

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

Conditions

Oxygen Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Desaturation

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

Group Type: EXPERIMENTAL

Desaturation

Intervention Type: DEVICE

The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.

Interventions

Desaturation

The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.

Intervention Type: DEVICE

Other Intervention Names

Cerebral and Tissue Oximeter

Eligibility Criteria

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]

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Katilius

Role: STUDY_DIRECTOR

Medtronic

Locations

Duke University Hospital, HPPL

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MDT16010MAVJB3

Identifier Type: -

Identifier Source: org_study_id