Assessment of Cerebral Blood Flow Asymmetry in Cardiac Surgery Patients Undergoing Hypothermic Circulatory Arrest

NCT03215589 | Terminated

• 1 other identifier: B2017:002
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral oxygen desaturation during cardiac surgery measured using near infrared spectroscopy (NIRS) derived cerebral oximetry has been associated with significant postoperative morbidity. If significant desaturation occurs during this period, it may represent an ideal opportunity to further optimize the postoperative care of these patients.

Conditions

Cerebral Desaturation; Cerebral Ischemia

Keywords

Near-infrared spectroscopy-derived cerebral oximetry

Outcome Measures

Primary Outcomes (1)

• Incidence of asymmetrical cerebral desaturation

  Cerebral desaturation defined as a greater than 10% difference in cerebral saturation comparing one hemisphere to the other based on a baseline reading taken in the minute preceding the onset of HCA to the end of the hypothermic period.

  Duration of hypothermic circulatory arrest between surgical induction and ICU admission

Secondary Outcomes (18)

• Severity of asymmetrical cerebral desaturation

  Duration of hypothermic circulatory arrest between surgical induction and ICU admission

• Severity of asymmetrical cerebral desaturation

  Duration of hypothermic circulatory arrest between surgical induction and ICU admission

• All cause mortality

  Surgical induction to 30 day postoperative

• Neurologic injury

  Surgical induction to 30 day postoperative

• Renal injury

  Surgical induction to 30 day postoperative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A convenience sample of 20 consecutive patients undergoing cardiac surgery employing CPB will be studied

You may qualify if:

• Informed consent
• Age 18 years or older
• Surgery requiring cardio pulmonary bypass
• Ascending aorta or arch repair surgery
• Surgery requiring hypothermic circulatory arrest

You may not qualify if:

• Off-pump cardiac surgery
• Skin condition preventing the use of cerebral oximetry pads

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H2A6, Canada

Location

Related Publications (2)

• Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.

  PMID: 17179242 BACKGROUND

• Fischer GW, Lin HM, Krol M, Galati MF, Di Luozzo G, Griepp RB, Reich DL. Noninvasive cerebral oxygenation may predict outcome in patients undergoing aortic arch surgery. J Thorac Cardiovasc Surg. 2011 Mar;141(3):815-21. doi: 10.1016/j.jtcvs.2010.05.017. Epub 2010 Jun 25.

  PMID: 20579669 BACKGROUND

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hilary P Grocott, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 12, 2017
• Study Start: July 3, 2017
• Primary Completion: July 3, 2018
• Study Completion: December 31, 2018
• Last Updated: February 17, 2020

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)