Cerebral Autoregulation Monitoring in Adults Undergoing Cardiac Surgery: Comparison of Near Infrared Spectroscopy With Transcranial Doppler
Sponsor study identifier
Secondary identifiers
NIH
observational
225
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2010
Actual (reported)Study Completion
July 2010
Actual (reported)Blood flow to the brain is normally regulated to ensure a constant supply of blood with oxygen and nutrients. During heart surgery using cardiopulmonary bypass, blood pressure is kept at a level that may or may not be below an individual's lower level of brain blood flow autoregulation. If lower, the brain may be exposed to an inadequate blood flow that could result in brain damage. The purpose of this study is to examine whether monitoring with a non-invasive FDA approved device that measures oxygen saturation of the superficial layers of the brain (near infrared spectroscopy) can, when combined with blood pressure measurements, provide information on the blood pressure level where brain blood flow is not autoregulated. The goal of this research is to develop a method to individualize blood pressure during surgery to a level that is within a patient's brain blood flow autoregulation range as a means for improving outcomes for patient undergoing heart surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
October 7, 2008
Actual (reported)October 9, 2008
Actual (reported)April 2010
Actual (reported)July 2010
Actual (reported)Concordance with Doppler measure
at complesion
Adult patients undergoing cardiac surgery
Adult patients undergoing cardiac surgery
Contact the study team to confirm eligibility.
The Johns Hopkins Hospital
Baltimore, Maryland, 21210, United States
Hori D, Katz NM, Fine DM, Ono M, Barodka VM, Lester LC, Yenokyan G, Hogue CW. Defining oliguria during cardiopulmonary bypass and its relationship with cardiac surgery-associated acute kidney injury. Br J Anaesth. 2016 Dec;117(6):733-740. doi: 10.1093/bja/aew340.
Hori D, Brown C, Ono M, Rappold T, Sieber F, Gottschalk A, Neufeld KJ, Gottesman R, Adachi H, Hogue CW. Arterial pressure above the upper cerebral autoregulation limit during cardiopulmonary bypass is associated with postoperative delirium. Br J Anaesth. 2014 Dec;113(6):1009-17. doi: 10.1093/bja/aeu319. Epub 2014 Sep 25.
Charles W Hogue, MD
Johns Hopkins University
225 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2008
First Posted
October 9, 2008
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Ono M, Zheng Y, Joshi B, Sigl JC, Hogue CW. Validation of a stand-alone near-infrared spectroscopy system for monitoring cerebral autoregulation during cardiac surgery. Anesth Analg. 2013 Jan;116(1):198-204. doi: 10.1213/ANE.0b013e318271fb10. Epub 2012 Dec 7.
Ono M, Joshi B, Brady K, Easley RB, Zheng Y, Brown C, Baumgartner W, Hogue CW. Risks for impaired cerebral autoregulation during cardiopulmonary bypass and postoperative stroke. Br J Anaesth. 2012 Sep;109(3):391-8. doi: 10.1093/bja/aes148. Epub 2012 Jun 1.
Brady K, Joshi B, Zweifel C, Smielewski P, Czosnyka M, Easley RB, Hogue CW Jr. Real-time continuous monitoring of cerebral blood flow autoregulation using near-infrared spectroscopy in patients undergoing cardiopulmonary bypass. Stroke. 2010 Sep;41(9):1951-6. doi: 10.1161/STROKEAHA.109.575159. Epub 2010 Jul 22.
Primary Completion
April 2010
Actual (reported)Study Completion
July 2010
Actual (reported)Last Updated
August 22, 2017
Record last verified: 2017-08
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