An interventional study of Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and An alarm threshold at 75% of the baseline rSO2 value in Cardiac Disease, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2017-06-01.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 250 is above the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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) · Other: An alarm threshold at 75% of the baseline rSO2 value
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.
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.
If the threshold of \< 75% from baseline is reached for \> 1 minute an algorithm geared to restore rSO2 to baseline levels will be implemented.
Number of patients who suffer from delirium postoperatively
Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively once a day during the first 7 postoperative days or until discharge.
Time frame: Delirium we be assessed postoperatively for 7 days or Discharge
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto