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Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

Primary Purpose

Cardiac Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter)
An alarm threshold at 75% of the baseline rSO2 value
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Disease focused on measuring Cardiac surgery, Delirium, Cerebral Oximetry

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Heatlh Network, Toronto General Hopsital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Near-infrared reflectance spectroscopy

Blinded Near-infrared reflectance spectroscopy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2011
Last Updated
May 31, 2017
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01707446
Brief Title
Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery
Official Title
Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease
Keywords
Cardiac surgery, Delirium, Cerebral Oximetry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Near-infrared reflectance spectroscopy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Blinded Near-infrared reflectance spectroscopy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
An alarm threshold at 75% of the baseline rSO2 value
Intervention Description
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 Outcome Measure Information:
Title
Number of patients who suffer from delirium postoperatively
Description
Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively once a day during the first 7 postoperative days or until discharge.
Time Frame
Delirium we be assessed postoperatively for 7 days or Discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Heatlh Network, Toronto General Hopsital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

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Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

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