Multi Modal Brain Monitoring and Cardiac Surgery

July 5, 2017 updated by: Dr Mohamed Shaaban Ali, PhD, MD, Assiut University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 74111
        • Recruiting
        • faculty of medicine Assiut university
        • Sub-Investigator:
          • Sayed K Abd-Elshafy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Emergency surgery
  • Hepatic
  • Renal impairment
  • Diabetes Mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

March 1, 2018

Study Completion (ANTICIPATED)

May 1, 2018

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 25, 2016

First Posted (ESTIMATE)

September 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00008715621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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