Multi Modal Brain Monitoring and Cardiac Surgery

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02916069
• Collaborator: (none)
• Enrollment: 1,200
• Location: 1
• Arms: 2
• Duration (Months): 19.9
• Patients Per Site Per Month: 60.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Neurophysiological Monitoring	Device: Nearinfrared Spectroscopy (NIRS); Device: Transcranial Doppler (TCD); Device: Bispectral index (BIS)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 1200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: The Impact Multi Modal Brain Monitoring on Patient Out Come After Adult Cardiac Surgery
• Study Start Date: Sep 1, 2016
• Anticipated Primary Completion Date: Mar 1, 2018
• Anticipated Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 (Multimodal brain monitoring) 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); Patients will be monitored and interference will be done to optimize the medical condition based on such monitor; Device: Transcranial Doppler (TCD); Patients will be monitored and interference will be done to optimize the medical condition based on such monitor; Device: Bispectral index (BIS); Patients will be monitored and interference will be done to optimize the medical condition based on such monitor
No Intervention: Group 2 Patients will be monitored without any interference based on such monitors

Outcome Measures

Primary Outcome Measures

1. S100 protein [up to 24 hours]

   S100 protein (marker of brain injury)

Secondary Outcome Measures

1. Mini-mental state examination [up to 30 days after surgery]

2. Western perioperative neurological scale [up to 30 days after surgery]

3. Major neurological out come as stoke [up to 30 days after surgery]

4. Duration of mechanical ventilation [up to 30 days after surgery]

5. Hospital stay [up to 30 days after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Elective cardiac surgery with cardiopulmonary bypass

• Valve replacement

• Coronary artery bypass

Exclusion Criteria:

• Emergency surgery

• Hepatic

• Renal impairment

• Diabetes Mellitus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine Assiut University	Assiut		Egypt	74111

Sponsors and Collaborators

• Assiut University

Investigators

• Principal Investigator: Mohamed Ali, PhD. MD, associate professor of anesthesia and critical care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Mohamed Shaaban Ali, PhD, MD, Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University, Assiut University
• ClinicalTrials.gov Identifier: NCT02916069
• Other Study ID Numbers: IRB00008715621
• First Posted: Sep 27, 2016
• Last Update Posted: Jul 6, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Dr Mohamed Shaaban Ali, PhD, MD, Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University, Assiut University: Spectroscopy; Transcranial Doppler; Bispectral index; Cardiac surgery

Study Results

No Results Posted as of Jul 6, 2017