Near Infrared Spectroscopy (NIRS)
This study has been completed.
Sponsor:
Nonin Medical, Inc
Information provided by (Responsible Party):
Nonin Medical, Inc
ClinicalTrials.gov Identifier:
NCT01429324
First received: September 2, 2011
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
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.
| Condition |
|---|
|
Aortic Arch Surgery |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Validation of Near Infrared Spectroscopy (NIRS) Neuro-monitoring During Deep Hypothermic Circulatory Arrest for Aortic Arch Surgery |
Resource links provided by NLM:
Further study details as provided by Nonin Medical, Inc:
Primary Outcome Measures:
- 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. [ Time Frame: At the end of the surgical case approximately 6 to 8 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine whether there are unilateral or global differences in cerebral tissue oxygenation detected during selective antegrade cerebral perfusion [ Time Frame: At the end of the surgical case approximately 6 to 8 hours ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | July 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Cardiac disease
Aortic arch surgery
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Mayo Clinic and affiliated hospitals
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429324
Locations
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Nonin Medical, Inc
Investigators
| Principal Investigator: | James J Lynch, MD | Mayo Clinic and affiliated hospitals |
More Information
No publications provided
| Responsible Party: | Nonin Medical, Inc |
| ClinicalTrials.gov Identifier: | NCT01429324 History of Changes |
| Other Study ID Numbers: | Mod11-000295-03 |
| Study First Received: | September 2, 2011 |
| Last Updated: | May 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nonin Medical, Inc:
|
Near infrared spectroscopy neuromonitoring aortic arch surgery |
ClinicalTrials.gov processed this record on May 22, 2013