Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

Not Applicable

Completed

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

• Registration Number: NCT01707446
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-12
• Study Start: 2012-01
• Study First Submitted QC: 2012-10-13
• Study First Posted: 2012-10-16
• Primary Completion: 2014-12
• Status Verified: 2016-05
• Study Completion: 2016-08
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

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Exclusion Criteria

• cardiac surgery without the use of cardiopulmonary bypass
• symptomatic cerebrovascular disease,
• history of delirium, or
• schizophrenia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Near-infrared reflectance spectroscopy	Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter)	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.
Near-infrared reflectance spectroscopy	An alarm threshold at 75% of the baseline rSO2 value	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.

Primary Outcome Measures

Name	Time	Method
Number of patients who suffer from delirium postoperatively	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.

Trial Locations

Locations (1)

University Heatlh Network, Toronto General Hopsital; 🇨🇦 Toronto, Ontario, Canada