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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01352260

Enrollment

Registered

2011-05-11

Start date

2011-05-31

Completion date

2012-04-30

Last updated

2012-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Aortic Arch Replacement

Keywords

Near Infrared Spectroscopy, Neuromonitoring, Aortic Arch Replacement

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results