Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01707446

Enrollment

250

Registered

2012-10-16

Start date

2012-01-31

Completion date

2016-08-31

Last updated

2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

Keywords

Cardiac surgery, Delirium, Cerebral Oximetry

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.

Interventions

DEVICECerebral 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.

OTHERAn 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026