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Near-Infrared Spectroscopy Comparison Study

This study has been completed.
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Nonin Medical, Inc
ClinicalTrials.gov Identifier:
NCT01352260
First received: May 10, 2011
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System, Somanetics; Troy, MI) with four-wavelength NIRS (Nonin Medical, Inc; Plymouth, MN) to determine which modality best correlates with jugular venous oxygen saturation


Condition
Total Aortic Arch Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Near-Infrared Spectroscopy for Neuromonitoring During Moderate Hypothermic Circulatory Arrest for Total Aortic Arch Replacement: A Comparison of Two Technologies With Jugular Venous Bulb Oximetry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nonin Medical, Inc:

Primary Outcome Measures:
  • Linear correlation between absolute value of cerebral oxygen saturation (rSO2) compared to Jugular Venous Oxygen Saturation (SjvO2). Sensitivity and specificity to detect < 60% desaturation. [ Time Frame: At the end of the surgical case approximately 6 to 8 hours ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: May 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac Disease
Total Aortic Arch Replacement

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Baylor College of Medicine and affiliated Hospitals

Criteria

Inclusion Criteria:

  1. Provide written informed consent from patient or legally authorized representative before surgery
  2. Adult patients 18-65 years of age
  3. Presenting for elective or urgent total aortic arch repair under moderate hypothermic circulatory arrest (Nasopharyngeal temperature 20 - 24 ºC) with selective antegrade cerebral perfusion -

Exclusion Criteria:

  1. Patients will be excluded from this study if they are age less than 18
  2. Are undergoing an emergent procedure
  3. Have a history of insulin-dependent diabetes mellitus
  4. Have a history of stroke
  5. Are undergoing a redo sternotomy during which major bleeding occurs necessitating transfusion of > 4 units of packed red blood cells prior to the institution of circulatory arrest
  6. Patients in whom a left jugular venous bulb cannula cannot successfully be placed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352260

Locations
United States, Texas
Baylor College of Medicine and affiliated Hospitals
Houston, Texas, United States, 77030
Sponsors and Collaborators
Nonin Medical, Inc
Baylor College of Medicine
Investigators
Principal Investigator: Wei Pan, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT01352260     History of Changes
Other Study ID Numbers: H-27855
Study First Received: May 10, 2011
Last Updated: May 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nonin Medical, Inc:
Near Infrared Spectroscopy
Neuromonitoring
Aortic Arch Replacement

ClinicalTrials.gov processed this record on May 19, 2013