Multi Modal Brain Monitoring and Cardiac Surgery

Intraoperative Neurophysiological Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02916069
• Other study ID #: IRB00008715621
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2016
• Last updated: July 5, 2017
• Start date: September 2016
• Est. completion date: May 2018

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: Mohamed Ali, PhD. MD
• Phone: 0020882413201
• Email: msali58[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: May 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Elective cardiac surgery with cardiopulmonary bypass

• Valve replacement

• Coronary artery bypass

Exclusion Criteria:

• Emergency surgery

• Hepatic

• Renal impairment

• Diabetes Mellitus

Related Conditions & MeSH terms

• Intraoperative Neurophysiological Monitoring

Intervention

Device:
• Nearinfrared Spectroscopy (NIRS)
Patients will be monitored and interference will be done to optimize the medical condition based on such monitor
• Transcranial Doppler (TCD)
Patients will be monitored and interference will be done to optimize the medical condition based on such monitor
• Bispectral index (BIS)
Patients will be monitored and interference will be done to optimize the medical condition based on such monitor

Locations

Country	Name	City	State
Egypt	Faculty of medicine Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S100 protein	S100 protein (marker of brain injury)	up to 24 hours
Secondary	Mini-mental state examination		up to 30 days after surgery
Secondary	Western perioperative neurological scale		up to 30 days after surgery
Secondary	Major neurological out come as stoke		up to 30 days after surgery
Secondary	Duration of mechanical ventilation		up to 30 days after surgery
Secondary	Hospital stay		up to 30 days after surgery