This trial is active, not recruiting.

Condition cardiac disease
Treatments cerebral oximetry monitor (the invos® cerebral/somatic oximeter), an alarm threshold at 75% of the baseline rso2 value
Sponsor University Health Network, Toronto
Start date January 2012
End date December 2014
Trial size 250 participants
Trial identifier NCT01707446, 11-0650-A


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(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.
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.
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)
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.

Primary Outcomes

Number of patients who suffer from delirium postoperatively
time frame: Delirium we be assessed postoperatively for 7 days or Discharge

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.