Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery
This study is currently recruiting participants.
Verified February 2013 by University Health Network, Toronto
Sponsor:
University Health Network, Toronto
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01707446
First received: December 12, 2011
Last updated: February 20, 2013
Last verified: February 2013
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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: | November 2013 |
| Estimated Primary Completion Date: | September 2013 (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
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: | February 20, 2013 |
| 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 Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013