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Validation of Next Generation Cerebral and Tissue Oximeter

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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:
Information provided by (Responsible Party):
Medtronic - MITG

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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




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.



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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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128372


Locations
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United States, North Carolina
Duke University Hospital, HPPL
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Medtronic - MITG
Investigators
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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


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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03128372     History of Changes
Other Study ID Numbers: MDT16010MAVJB3
First Posted: April 25, 2017    Key Record Dates
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

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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:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms