NCT03351985

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

November 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

November 14, 2017

Last Update Submit

November 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • amplitude integrated electroencephalogram (aEEG)

    the electroencephalogram amplitude of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit

    24 hours

Secondary Outcomes (12)

  • alpha frequency band energy

    24 hours

  • beta frequency band energy

    24 hours

  • theta frequency band energy

    24 hours

  • delta frequency band energy

    24 hours

  • alpha variability

    24 hours

  • +7 more secondary outcomes

Study Arms (2)

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)

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)

Interventions

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

Delirium GroupNon-delirium Group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients receiving cardiac surgery

You may qualify if:

  • The patients of cardiac surgery aged ≥18 years
  • Signed informed consent

You may not qualify if:

  • Patients with a history of any neurologic and psychiatric disease
  • Cognitive disorder
  • Stroke history in three years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Guo Z, Wan W, Liu W, Liu L, Yang Y, Yang C, Cui X. Quantitative electroencephalography predicts postoperative delirium in adult cardiac surgical patients from a prospective observational study. Sci Rep. 2024 Dec 28;14(1):31101. doi: 10.1038/s41598-024-82422-7.

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Liu Wenxue, master

    Southeast University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Wenxue, master

CONTACT

Yang Congshan, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 24, 2017

Study Start

December 1, 2017

Primary Completion

June 30, 2018

Study Completion

August 31, 2018

Last Updated

November 24, 2017

Record last verified: 2017-11