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Completed

NCT Number: NCT01352260

Near-Infrared Spectroscopy Comparison Study

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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Key information

Conditions

Total Aortic Arch Replacement

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor College of Medicine and affiliated Hospitals

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Exclusion criteria

  • 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

Treatment and study plan

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.

    Time frame: At the end of the surgical case approximately 6 to 8 hours

Sponsors and collaborators

Lead sponsor

Nonin Medical, Inc

Industry

Collaborators

  • Baylor College of Medicine

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 11, 2011
Registry last updated
May 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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