Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT01707446|
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : June 1, 2017
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 or disease||Intervention/treatment||Phase|
|Cardiac Disease||Device: Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) Other: An alarm threshold at 75% of the baseline rSO2 value||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||August 2016|
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.
- Number of patients who suffer from delirium postoperatively [ Time Frame: Delirium we be assessed postoperatively for 7 days or Discharge ]Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively once a day during the first 7 postoperative days or until discharge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707446
|University Heatlh Network, Toronto General Hopsital|
|Toronto, Ontario, Canada, M5G 2C4|