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
1 other identifier
observational
17
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMay 21, 2012
May 1, 2012
11 months
May 10, 2011
May 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Cardiac Disease
Total Aortic Arch Replacement
Eligibility Criteria
Baylor College of Medicine and affiliated Hospitals
You may qualify if:
- Provide written informed consent from patient or legally authorized representative before surgery
- Adult patients 18-65 years of age
- Presenting for elective or urgent total aortic arch repair under moderate hypothermic circulatory arrest (Nasopharyngeal temperature 20 - 24 ºC) with selective antegrade cerebral perfusion -
You may not qualify if:
- Patients will be excluded from this study if they are age less than 18
- Are undergoing an emergent procedure
- Have a history of insulin-dependent diabetes mellitus
- Have a history of stroke
- 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
- Patients in whom a left jugular venous bulb cannula cannot successfully be placed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nonin Medical, Inclead
- Baylor College of Medicinecollaborator
Study Sites (1)
Baylor College of Medicine and affiliated Hospitals
Houston, Texas, 77030, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Pan, MD
Baylor College of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2011
First Posted
May 11, 2011
Study Start
May 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
May 21, 2012
Record last verified: 2012-05