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Recruiting NCT04832568

Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery

— Observational Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Delirium. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery: a Prospective Observational Study

Overview

Postoperative delirium is common in patients undergoing cardiovascular surgery and associated with poor outcomes. However the pathogenesis of postoperative delirium is poorly understood. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of postoperative delirium in patients undergoing cardiovascular surgery using electroencephalogram.

Primary outcome measures

  • Incidence of postoperative delirium [Time frame: After surgery through to postoperative day 7]
Secondary outcome measures (7)
  • Relative power of each brain waves [Time frame: During the stay of the patient in the operating room, after surgery through to postoperative day 7]
  • Duration of delirium [Time frame: After surgery through to postoperative day 7]
  • Severity of delirium [Time frame: After surgery through to postoperative day 7]
  • Worst daily pain scores at rest [Time frame: After surgery through to postoperative day 7]
  • Worst daily pain scores with exertion (deep breathing and cough) [Time frame: After surgery through to postoperative day 7]
  • Length of stay in the Intensive Care Unit (ICU) [Time frame: through study completion, an average of 5 days]
  • Length of hospital stay [Time frame: through study completion, an average of 10 days]

Eligibility criteria

Inclusion criteria

  • age of at least 18 years
  • normal cognitive function at the time of enrollment evidenced by a Mini-Mental State Examination (MMSE) score of more than 24 of 30
  • Chinese Mandarin as the native language
  • providing informed consent

Exclusion criteria

  • pre-existing delirium assessed according to the Confusion Assessment Method (CAM)
  • history of neurological or psychiatric disease
  • impaired vision or auditory function which may effect the assessments
  • unwillingness to participate in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong Univers — Wuhan

Identifiers

NCT: NCT04832568 · TJMZK202101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗