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OpenTrials
Completed

NCT Number: NCT01707446

Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

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.

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Confusion Delirium Heart Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Heatlh Network, Toronto General Hopsital

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Oct 16, 2012
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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