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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014