Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Cardiac Disease
Device: Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter)
Other: An alarm threshold at 75% of the baseline rSO2 value

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 266
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707446

Contacts
Contact: George Djaiani, MD 416-340-4800 ext 6205 george.djaiani@uhn.ca

Locations
Canada, Ontario
University Heatlh Network, Toronto General Hopsital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: George Djaiani, MD    416-340-4800 ext 6205    george.djaiani@uhn.ca   
Sub-Investigator: Rita Katznelson, MD         
Sub-Investigator: Rima Styra, MD         
Principal Investigator: George Djaiani, MD         
Sub-Investigator: Vivek Rao, MD         
Sub-Investigator: Marcin Wasowicz, MD         
Sub-Investigator: Jacek Karski, MD         
Sponsors and Collaborators
University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01707446     History of Changes
Other Study ID Numbers: 11-0650-A
Study First Received: December 12, 2011
Last Updated: May 21, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Cardiac surgery
Delirium
Cerebral Oximetry

Additional relevant MeSH terms:
Delirium
Heart Diseases
Cardiovascular Diseases
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014