NCT01429324

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

Enrollment Period

10 months

First QC Date

September 2, 2011

Last Update Submit

May 18, 2012

Conditions

Aortic Arch Surgery

Keywords

Near infrared spectroscopyneuromonitoringaortic arch surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (1)

Cardiac disease

Aortic arch surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mayo Clinic and affiliated hospitals

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • James J Lynch, MD

    Mayo Clinic and affiliated hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2011

First Posted

September 7, 2011

Study Start

July 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 21, 2012

Record last verified: 2012-05

Locations

US(1)