NCT02916069

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

1.5 years

First QC Date

September 16, 2016

Last Update Submit

July 5, 2017

Conditions

Intraoperative Neurophysiological Monitoring

Keywords

SpectroscopyTranscranial DopplerBispectral indexCardiac surgery

Outcome Measures

Primary Outcomes (1)

  • S100 protein

    S100 protein (marker of brain injury)

    up to 24 hours

Secondary Outcomes (5)

  • Mini-mental state examination

    up to 30 days after surgery

  • Western perioperative neurological scale

    up to 30 days after surgery

  • Major neurological out come as stoke

    up to 30 days after surgery

  • Duration of mechanical ventilation

    up to 30 days after surgery

  • Hospital stay

    up to 30 days after surgery

Study Arms (2)

Group 1 (Multimodal brain monitoring)

ACTIVE COMPARATOR

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)Device: Transcranial Doppler (TCD)Device: Bispectral index (BIS)

Group 2

NO INTERVENTION

Patients will be monitored without any interference based on such monitors

Interventions

Nearinfrared Spectroscopy (NIRS)DEVICE

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

Group 1 (Multimodal brain monitoring)
Transcranial Doppler (TCD)DEVICE

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

Group 1 (Multimodal brain monitoring)
Bispectral index (BIS)DEVICE

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

Group 1 (Multimodal brain monitoring)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Emergency surgery
  • Hepatic
  • Renal impairment
  • Diabetes Mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Assiut University

Asyut, 74111, Egypt

RECRUITING

MeSH Terms

Interventions

Ultrasonography, Doppler, TranscranialConsciousness Monitors

Intervention Hierarchy (Ancestors)

EchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative TechniquesSurgical EquipmentEquipment and Supplies

Study Officials

  • Mohamed Ali, PhD. MD

    associate professor of anesthesia and critical care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Ali, PhD. MD

CONTACT

0020882413201msali58@hotmail.com

Sayed K Abd-Elshafy, MD

CONTACT

0020882413201sayed_k_72@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Study Record Dates

First Submitted

September 16, 2016

First Posted

September 27, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

July 6, 2017

Record last verified: 2017-07

Locations

EG(1)