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

Study Overview

• Status: Completed
• Conditions: Total Aortic Arch Replacement

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine and affiliated Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Baylor College of Medicine and affiliated Hospitals

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiac Disease; Total Aortic Arch Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Linear correlation between absolute value of cerebral oxygen saturation (rSO2) compared to Jugular Venous Oxygen Saturation (SjvO2). Sensitivity and specificity to detect < 60% desaturation.	At the end of the surgical case approximately 6 to 8 hours

Collaborators and Investigators

• Sponsor: Nonin Medical, Inc
• Collaborators: Baylor College of Medicine
• Investigators: Principal Investigator: Wei Pan, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: May 10, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimate): May 11, 2011

Study Record Updates

• Last Update Posted (Estimate): May 21, 2012
• Last Update Submitted That Met QC Criteria: May 18, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Near Infrared Spectroscopy; Neuromonitoring; Aortic Arch Replacement
• Other Study ID Numbers: H-27855