Postoperative Delirium in Cardiac Surgery ICU

Study on Visual Assessment System and Stratified Management Program for Postoperative Delirium After Cardiac Surgery

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04527341

Enrollment

500

Registered

2020-08-26

Start date

2021-01-01

Completion date

2022-09-30

Last updated

2020-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

postoperative delirium, cardiac surgery, Intensive care unit, risk assessment

Brief summary

Postoperative Delirium (POD) is a common complication in patients after cardiac surgery, which is associated with short-term prognosis and long-term quality of life. Due to the lack of specific treatment, prevention is the most effective strategy to reduce delirium. Risk assessment greatly contributes to guide prevention by stratifying the risk of the POD. However, the high-quality risk assessment tools are still sparse, and the combination of risk assessment and stratified prevention has not been applied to the management of delirium after cardiac surgery. In the previous work, we found the predictive value of preoperative cardiac function on POD, and found a critical value. On the basis of previous research, this project will learn from previous studies on risk factors of POD, and deeply explore potential predictors. Furthermore, we will develop and validate POD risk prediction model, and then develop it into a visual evaluation system. In addition, based on the theory of risk management and risk assessment tools, using the concepts and methods of evidence-based medicine, the risk assessment system and stratified management program of POD will be formed and evaluated by expert discussion meetings. It is expected that the risk assessment system and stratified management program constructed by this project could simply and quickly screen high-risk patients and carry out timely intervention, so as to reduce the incidence of POD, improve patients' prognosis and the quality of life after cardiac surgery.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Aged above 18 * Patients after cardiac surgery * Admitted to ICU after surgery

Exclusion criteria

* Preoperative delirium or dementia patients * Unable to fully participate in delirium testing, including blind, deaf, illiterate or inability to understand Chinese * Undergoing surgery procedures do not require admission to SICU * Transfer to ICU from wards after surgery

Design outcomes

Primary

Measure	Time frame	Description
Incidence of postoperative delirium	up to 5 days postoperatively	Investigators defined patients have delirium if they had at least one positive screening during ICU stay.

Secondary

Measure	Time frame	Description
Severity of postoperative delirium	up to 5 days postoperatively	Assess by CAM-ICU-7 if CAM-ICU is positive. Categorized as no delirium: 0-2, mild to moderate delirium: 3-5, and severe delirium: 6-7
duration of postoperative delirium	up to 5 days postoperatively	Defined as time (in days) from the first positive CAM-ICU until the beginning of two consecutive days of negative CAM-ICU.

Outcome results