Validation of Next Generation Cerebral and Tissue Oximeter

Oxygen Deficiency Clinical Trial

Official title:

Validation of Next Generation INVOS NIRS Cerebral and Tissue Oximeter to Measure Cerebral and Somatic Tissue Oxygen Saturation in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128372
• Other study ID #: MDT16010MAVJB3
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: July 19, 2017

Study information

• Verified date: October 2018
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 19, 2017
• Est. primary completion date: July 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 46 Years

Eligibility

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]

Related Conditions & MeSH terms

• Hypoxia
• Oxygen Deficiency

Intervention

Device:
• 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%.

Locations

Country	Name	City	State
United States	Duke University Hospital, HPPL	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validated the Next Generation Oximeter	Cerebral overall mean bias (percentage saturation) defined as the average of the differences between the regional saturation (rSO2) value and (fSO2) value obtained from simultaneous arterial and jugular venous blood samples. Cerebral trending is defined as the measurement of changes in regional saturation (rSO2) under conditions of changing fSO2. Cerebral trending mean bias is the average difference between changes in rSO2 values compared against changes in fSO2. Somatic trending mean bias is defined the same as Cerebral trending mean bias except for the location of measurement on the subjects and for Somatic trending mean bias, rS02 was compared to rSO2 on a commercially-available regional oximetry monitor. The smaller value the better performance.	Data collected from individual participant over 4 hour timeframe.