Multi Modal Brain Monitoring and Cardiac Surgery

NCT ID: NCT02916069

Last Updated: 2017-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Intraoperative Neurophysiological Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Nearinfrared Spectroscopy (NIRS)

Intervention Type DEVICE

Patients will be monitored and interference will be done to optimize the medical condition based on such monitor

Transcranial Doppler (TCD)

Intervention Type DEVICE

Patients will be monitored and interference will be done to optimize the medical condition based on such monitor

Bispectral index (BIS)

Intervention Type DEVICE

Patients will be monitored and interference will be done to optimize the medical condition based on such monitor

Group 2

Patients will be monitored without any interference based on such monitors

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nearinfrared Spectroscopy (NIRS)

Patients will be monitored and interference will be done to optimize the medical condition based on such monitor

Intervention Type DEVICE

Transcranial Doppler (TCD)

Patients will be monitored and interference will be done to optimize the medical condition based on such monitor

Intervention Type DEVICE

Bispectral index (BIS)

Patients will be monitored and interference will be done to optimize the medical condition based on such monitor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Emergency surgery
* Hepatic
* Renal impairment
* Diabetes Mellitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Dr Mohamed Shaaban Ali, PhD, MD

Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Ali, PhD. MD

Role: PRINCIPAL_INVESTIGATOR

associate professor of anesthesia and critical care

Locations

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Faculty of medicine Assiut University

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Ali, PhD. MD

Role: CONTACT

0020882413201

Sayed K Abd-Elshafy, MD

Role: CONTACT

0020882413201

Other Identifiers

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IRB00008715621

Identifier Type: -

Identifier Source: org_study_id

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