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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

May 10, 2011
May 18, 2012
May 2011
April 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01352260 on ClinicalTrials.gov Archive Site
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Near-Infrared Spectroscopy Comparison Study
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

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

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Baylor College of Medicine and affiliated Hospitals

Total Aortic Arch Replacement
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Cardiac Disease
Total Aortic Arch Replacement
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01352260
H-27855
No
Nonin Medical, Inc
Nonin Medical, Inc
Baylor College of Medicine
Principal Investigator: Wei Pan, MD Baylor College of Medicine
Nonin Medical, Inc
May 2012

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