Validation of Next Generation Cerebral and Tissue Oximeter

• ClinicalTrials.gov Identifier: NCT03128372
• Recruitment Status: Completed
• First Posted: April 25, 2017
• Results First Posted: November 9, 2018
• Last Update Posted: November 9, 2018
• Sponsor: Medtronic - MITG
• Information provided by (Responsible Party): Medtronic - MITG

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Oxygen Deficiency	Device: Desaturation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Validation of Next Generation INVOS NIRS Cerebral and Tissue Oximeter to Measure Cerebral and Somatic Tissue Oxygen Saturation in Healthy Volunteers
• Actual Study Start Date: May 22, 2017
• Actual Primary Completion Date: July 19, 2017
• Actual Study Completion Date: July 19, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Desaturation; Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.	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%.; Other Name: Cerebral and Tissue Oximeter

Outcome Measures

Primary Outcome Measures :

1. Validated the Next Generation Oximeter [ Time Frame: Data collected from individual participant over 4 hour timeframe. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 46 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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]

Contacts and Locations

Locations

United States, North Carolina

Duke University Hospital, HPPL

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Medtronic - MITG

Investigators

• Study Director: Julia Katilius; Medtronic

  Study Documents (Full-Text)

Documents provided by Medtronic - MITG:

Study Protocol  [PDF] March 15, 2017

Statistical Analysis Plan  [PDF] July 18, 2017

More Information

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT03128372 History of Changes
• Other Study ID Numbers: MDT16010MAVJB3
• First Posted: April 25, 2017
• Results First Posted: November 9, 2018
• Last Update Posted: November 9, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Pediatric Postmarket Surveillance of a Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms