Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

This study is currently recruiting participants.
Verified October 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01707446
First received: December 12, 2011
Last updated: October 4, 2013
Last verified: October 2013

December 12, 2011
October 4, 2013
January 2012
March 2014   (final data collection date for primary outcome measure)
Number of patients who suffer from delirium postoperatively [ Time Frame: Delirium we be assessed postoperatively for 7 days or Discharge ] [ Designated as safety issue: No ]
Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively once a day during the first 7 postoperative days or until discharge.
Same as current
Complete list of historical versions of study NCT01707446 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery
Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a serious complication that results in prolonged length of stay, increased health care costs and is associated with higher death rates. The exact cause involved in the development of delirium after cardiac surgery is unclear. The latest advancement in near-infrared spectroscopy (NIRS) Oximetry offers real-time management of patients at risk of brain injury. This approved device will monitor cerebral oxygenation during and 24hr after cardiac surgery, recording oxygenation in real time allowing the clinical team the opportunity to intervene early to prevent ischemia and possibly preventing untoward events. Adverse events followed include, but are not limited to, stroke, (transient ischemic attacks), heart attack, (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure, pneumonia, cause of death for 30-days after surgery (all cause mortality).

Hypothesis: Perioperative restoration of rSO2 desaturation to baseline values results in lower delirium rates after complex cardiac surgery.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cardiac Disease
  • Device: Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter)
    In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established. Based on predetermined algorithm the rSO2 will be maintained at or above 75% of the baseline measurements.
  • Other: An alarm threshold at 75% of the baseline rSO2 value
    If the threshold of < 75% from baseline is reached for > 1 minute an algorithm geared to restore rSO2 to baseline levels will be implemented.
  • Active Comparator: Near-infrared reflectance spectroscopy
    Bilateral NIRS (The INVOS® Cerebral/Somatic Oximeter)will be used to measure rSO2 intraoperatively and during the 24h postoperative period in the intensive care unit. In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established.
    Interventions:
    • Device: Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter)
    • Other: An alarm threshold at 75% of the baseline rSO2 value
  • No Intervention: Blinded Near-infrared reflectance spectroscopy
    In the control group, the NIRS monitor screen will be electronically blinded, however, the recording will be continuous after verification of the signal strength and baseline value by an independent observer trained in NIRS application and unaware of the study design.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
266
July 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age > 60 years
  • combined valve and CABG
  • repeat cardiac surgery
  • multiple valve replacement or repair
  • surgery of ascending aorta and aortic arch
  • signed informed consent.

Exclusion Criteria:

  • cardiac surgery without the use of cardiopulmonary bypass
  • symptomatic cerebrovascular disease,
  • history of delirium, or
  • schizophrenia
Both
60 Years and older
No
Contact: George Djaiani, MD 416-340-4800 ext 6205 george.djaiani@uhn.ca
Canada
 
NCT01707446
11-0650-A
No
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Not Provided
University Health Network, Toronto
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP