Multi Modal Brain Monitoring and Cardiac Surgery

Study Overview
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Brief Summary
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Multimodal brain monitoring is feasible and can be used in formulating therapeutic strategies during cardiac surgery. Such monitoring may help to improve patient outcome and to reduce costs after cardiac surgery with CPB.

Detailed Description
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The aim of this study is to use a combination of brain monitoring {Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), bispectral index (BIS)} to formulate therapeutic strategies based on these monitors and to evaluate the impact on patient outcome.

Official Title
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The Impact Multi Modal Brain Monitoring on Patient Out Come After Adult Cardiac Surgery

Conditions
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Intraoperative Neurophysiological Monitoring

Intervention / Treatment
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* Device: Nearinfrared Spectroscopy (NIRS)
* Device: Transcranial Doppler (TCD)
* Device: Bispectral index (BIS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective cardiac surgery with cardiopulmonary bypass Valve replacement Coronary artery bypass Exclusion Criteria: Emergency surgery Hepatic Renal impairment Diabetes Mellitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (Multimodal brain monitoring)<br>Patients will be monitored with combination of brain monitoring; Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), and Bispectral index (BIS). Interference will be done to optimize the medical condition based on such monitors. | Device: Nearinfrared Spectroscopy (NIRS)<br>* Patients will be monitored and interference will be done to optimize the medical condition based on such monitor<br>Device: Transcranial Doppler (TCD)<br>* Patients will be monitored and interference will be done to optimize the medical condition based on such monitor<br>Device: Bispectral index (BIS)<br>* Patients will be monitored and interference will be done to optimize the medical condition based on such monitor<br>|
| No Intervention: Group 2<br>Patients will be monitored without any interference based on such monitors | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S100 protein | S100 protein (marker of brain injury) | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-mental state examination |  | up to 30 days after surgery | 
| Western perioperative neurological scale |  | up to 30 days after surgery | 
| Major neurological out come as stoke |  | up to 30 days after surgery | 
| Duration of mechanical ventilation |  | up to 30 days after surgery | 
| Hospital stay |  | up to 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spectroscopy, Transcranial Doppler, Bispectral index, Cardiac surgery