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Trial record 15 of 643 for:    oximeter

Validation of Next Generation Cerebral and Tissue Oximeter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 5, 2017
First Posted Date  ICMJE April 25, 2017
Results First Submitted Date  ICMJE July 20, 2018
Results First Posted Date  ICMJE November 9, 2018
Last Update Posted Date November 9, 2018
Actual Study Start Date  ICMJE May 22, 2017
Actual Primary Completion Date July 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
Validate that the production equivalent PM7100 System in conjunction with Adult Sensors (PMSENS71-A) [ Time Frame: Data collected from individual participant over 4 hour timeframe. ]
INVOS regional hemoglobin oxygen saturation (rSO2) performance will be compared to the calculated global field saturation (fSO2) value obtained from simultaneous collected arterial and jugular venous blood samples for the cerebral site.
Change History Complete list of historical versions of study NCT03128372 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of Next Generation Cerebral and Tissue Oximeter
Official Title  ICMJE Validation of Next Generation INVOS NIRS Cerebral and Tissue Oximeter to Measure Cerebral and Somatic Tissue Oxygen Saturation in Healthy Volunteers
Brief Summary This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Oxygen Deficiency
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Desaturation
Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.
Intervention: Device: Desaturation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2017)
32
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2017)
30
Actual Study Completion Date  ICMJE July 19, 2017
Actual Primary Completion Date July 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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]
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 46 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03128372
Other Study ID Numbers  ICMJE MDT16010MAVJB3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic - MITG
Study Sponsor  ICMJE Medtronic - MITG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Julia Katilius Medtronic
PRS Account Medtronic - MITG
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP