Validation of Next Generation Cerebral and Tissue Oximeter

NCT03128372 | Completed Results FDA Device

• 1 other identifier: MDT16010MAVJB3
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Desaturation

EXPERIMENTAL

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

Device: Desaturation

Interventions

Desaturation 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%.

Also known as: Cerebral and Tissue Oximeter

Desaturation

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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) \[self-reported\];
• Taking any medication other than birth control \[self-reported\];
• 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 \[self-reported\];
• Has a negative Allen's Test to confirm non-patency of the collateral artery \[clinical assessment by PI or delegate\];
• Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\];
• 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;
• 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 \[POC testing\];
• 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% \[measured by venous blood sample co-oximetry\]

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Duke University Hospital, HPPL

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Julia Katilius
• Organization: Medtronic

julia.z.katilius@medtronic.com

1 303-305-2278

Study Officials

• Julia Katilius

  Medtronic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 25, 2017
• Study Start: May 22, 2017
• Primary Completion: July 19, 2017
• Study Completion: July 19, 2017
• Last Updated: November 9, 2018
• Results First Posted: November 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)