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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03351985
• Other study ID #: 2017ZDSYLL054-P01
• Status: Not yet recruiting
• Phase: N/A
• First received: November 14, 2017
• Last updated: November 21, 2017
• Start date: December 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: November 2017
• Source: Southeast University, China
• Contact: Liu Wenxue, master
• Phone: 15751866806
• Email: diligent_hi[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: August 31, 2018
• Est. primary completion date: June 30, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Device:
• quantitative electroencephalogram (qEEG)
the patients receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Outcome

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