Multi Modal Brain Monitoring and Cardiac Surgery

Not Applicable

• Conditions: Intraoperative Neurophysiological Monitoring
• Interventions: Device: Nearinfrared Spectroscopy (NIRS); Device: Transcranial Doppler (TCD); Device: Bispectral index (BIS)

• Registration Number: NCT02916069
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-09-25
• Study First Posted: 2016-09-27
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-06
• Primary Completion: 2018-03
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

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

Exclusion Criteria

• Emergency surgery
• Hepatic
• Renal impairment
• Diabetes Mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Multimodal brain monitoring)	Bispectral index (BIS)	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.
Group 1 (Multimodal brain monitoring)	Nearinfrared Spectroscopy (NIRS)	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.
Group 1 (Multimodal brain monitoring)	Transcranial Doppler (TCD)	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.

Primary Outcome Measures

Name	Time	Method
S100 protein	up to 24 hours	S100 protein (marker of brain injury)

Secondary Outcome Measures

Name	Time	Method
Major neurological out come as stoke	up to 30 days after surgery
Mini-mental state examination	up to 30 days after surgery
Duration of mechanical ventilation	up to 30 days after surgery
Hospital stay	up to 30 days after surgery
Western perioperative neurological scale	up to 30 days after surgery

Trial Locations

Locations (1)

Faculty of medicine Assiut University; 🇪🇬 Assiut, Egypt