Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

NCT01707446 | Completed

• 1 other identifier: 11-0650-A
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease

Keywords

Cardiac surgery; Delirium; Cerebral Oximetry

Outcome Measures

Primary Outcomes (1)

• 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.

  Delirium we be assessed postoperatively for 7 days or Discharge

Study Arms (2)

Near-infrared reflectance spectroscopy

ACTIVE COMPARATOR

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

Blinded Near-infrared reflectance spectroscopy

NO INTERVENTION

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.

Interventions

Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) DEVICE

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.

Near-infrared reflectance spectroscopy

An alarm threshold at 75% of the baseline rSO2 value OTHER

If the threshold of \< 75% from baseline is reached for \> 1 minute an algorithm geared to restore rSO2 to baseline levels will be implemented.

Near-infrared reflectance spectroscopy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Heatlh Network, Toronto General Hopsital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Heart Diseases; Delirium

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: October 16, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: August 1, 2016
• Last Updated: June 1, 2017

Record last verified: 2016-05

Locations

CA (1)