Postoperative Delirium in Cardiac Surgery ICU

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

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.

Study Overview

• Status: Unknown
• Conditions: Delirium

• Study Type: Observational
• Enrollment (Anticipated): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged above 18 who are admitted to surgical ICUs after cardiac surgery will be screened for eligibility.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
cardiac surgery patients in ICU

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of postoperative delirium	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	up to 5 days postoperatively
duration of postoperative delirium	Defined as time (in days) from the first positive CAM-ICU until the beginning of two consecutive days of negative CAM-ICU.	up to 5 days postoperatively

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 23, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 23, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: cardiac surgery; Intensive care unit; risk assessment; postoperative delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: SKQN2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No