Multi Modal Brain Monitoring and Cardiac Surgery

Assiut University

Status: Unknown

Conditions: Intraoperative Neurophysiological Monitoring

Treatments: Device: Bispectral index (BIS); Device: Nearinfrared Spectroscopy (NIRS); Device: Transcranial Doppler (TCD)

Study type: Interventional

Funder types: Other

Identifiers

NCT02916069

IRB00008715621

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective cardiac surgery with cardiopulmonary bypass
• Valve replacement
• Coronary artery bypass

Exclusion criteria

• Emergency surgery
• Hepatic
• Renal impairment
• Diabetes Mellitus

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,200 participants in 2 patient groups

Group 1 (Multimodal brain monitoring)

Active Comparator group

Description:

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.

Treatment:

Device: Transcranial Doppler (TCD)

Device: Bispectral index (BIS)

Device: Nearinfrared Spectroscopy (NIRS)

Group 2

No Intervention group

Description:

Patients will be monitored without any interference based on such monitors