Near Infrared Spectroscopy (NIRS)

Aortic Arch Surgery Clinical Trial

Official title:

Validation of Near Infrared Spectroscopy (NIRS) Neuro-monitoring During Deep Hypothermic Circulatory Arrest for Aortic Arch Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429324
• Other study ID #: Mod11-000295-03
• Status: Completed
• Phase: N/A
• First received: September 2, 2011
• Last updated: May 18, 2012
• Start date: July 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Nonin Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study is designed to assess the feasibility of evaluating cerebral saturation during critical periods of deep hypothermia circulatory arrest and Selective Antegrade Cerebral Perfusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Is male or female

• Is of any race or ethnicity

• Is greater than or equal to eighteen (18) years of age

• Weighs greater than or equal to 40 kilogram

• Is not known to be pregnant

• Understands English

• Is undergoing aortic arch surgery with planned deep hypothermia circulatory arrest, either with or without select antegrade cerebral perfusion

• Is able and willing to provide informed consent

Exclusion Criteria:

• Is less than eighteen (18) years of age

• Weighs less than 40 kilogram

• Is known to be pregnant

• Does not understand English

• Has known sensitivity to adhesives

• Is unable or unwilling to provide informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Arch Surgery

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Nonin Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate brain tissue oxygenation assessing the number and percentage of subjects from whom regional data could be collected during 90% of the aortic arch surgery, and the registration rate during deep hypothermic circulatory arrest.		At the end of the surgical case approximately 6 to 8 hours	No
Secondary	Determine whether there are unilateral or global differences in cerebral tissue oxygenation detected during selective antegrade cerebral perfusion		At the end of the surgical case approximately 6 to 8 hours	No