The Study of Post-operation Delirium and Prognosis of Cardiac Surgery Patients

November 21, 2017 updated by: Jingyuan,Xu, Southeast University, China

the Effect of Quantitative Electroencephalogram (qEEG) in Predictive of Post-operation Delirium and Prognosis of Cardiac Surgery Patients

Delirium is the most common neurological complication of cardiac surgery patients and associated with poor prognosis. In recent years, the important role of quantitative electroencephalogram (qEEG) in brain function monitoring is becoming increasingly prominent. The purpose of this study is to evaluate the effect of qEEG in predictive of post-operation delirium and prognosis of cardiac surgery patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

56

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 Contact Backup

  • Name: Yang Congshan, professor
  • Phone Number: 13851462550
  • Email: ycs7415@163.com

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients receiving cardiac surgery

Description

Inclusion Criteria:

  1. The patients of cardiac surgery aged ≥18 years
  2. Signed informed consent

Exclusion Criteria:

  1. Patients with a history of any neurologic and psychiatric disease
  2. Cognitive disorder
  3. Stroke history in three years

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Delirium Group
The cardiac surgery patients with delirium receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU
Device: quantitative electroencephalogram (qEEG)
the patients receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU
Non-delirium Group
The cardiac surgery patients without delirium receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU
Device: quantitative electroencephalogram (qEEG)
the patients receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amplitude integrated electroencephalogram (aEEG)
Time Frame: 24 hours
the electroencephalogram amplitude of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
alpha frequency band energy
Time Frame: 24 hours
the percentage of alpha frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
24 hours
beta frequency band energy
Time Frame: 24 hours
the percentage of beta frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
24 hours
theta frequency band energy
Time Frame: 24 hours
the percentage of theta frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
24 hours
delta frequency band energy
Time Frame: 24 hours
the percentage of delta frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
24 hours
alpha variability
Time Frame: 24 hours
the variability of alpha frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
24 hours
arterial oxygen saturation (SaO2)
Time Frame: 24 hours
the level of arterial oxygen saturation (SaO2) of cardiac surgery patients when admitted to intensive care unit
24 hours
central venous oxygen saturation (ScvO2)
Time Frame: 24 hours
the level of central venous oxygen saturation(ScvO2) of cardiac surgery patients when admitted to intensive care unit
24 hours
neuron specific enolase (NSE)
Time Frame: 24 hours
the level of neuron specific enolase (NSE) of cardiac surgery patients when admitted to intensive care unit
24 hours
interleukin-6 (IL-6)
Time Frame: 24 hours
the level of interleukin-6 (IL-6) of cardiac surgery patients when admitted to intensive care unit
24 hours
troponin i (TNI)
Time Frame: 24 hours
the level of troponin i (TNI) of cardiac surgery patients when admitted to intensive care unit
24 hours
high-sensitivity C-reactive protein (hs-CRP)
Time Frame: 24 hours
the level of high-sensitivity C-reactive protein (hs-CRP) of cardiac surgery patients when admitted to intensive care unit
24 hours
N-terminal pro brain natriuretic peptide (NT-pro-BNP)
Time Frame: 24 hours
the level of N-terminal pro brain natriuretic peptide (NT-pro-BNP) of cardiac surgery patients when admitted to intensive care unit
24 hours

Collaborators and Investigators

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

Sponsor

Southeast University, China

Investigators

  • Principal Investigator: Liu Wenxue, master, Southeast university

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 (Anticipated)

December 1, 2017

Primary Completion (Anticipated)

June 30, 2018

Study Completion (Anticipated)

August 31, 2018

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017ZDSYLL054-P01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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