Incidence and Predictors of Delirium in the Trauma Intensive Care Unit：Prospective Study

Background Delirium is an acute neuropsychiatric syndrome, and its causes remain complex and not fully comprehended. Patients in trauma intensive care units are at high risk for delirium and are greatly affected by its adverse outcomes. As there are currently no effective pharmacological treatments or approaches for delirium, it is crucial to focus on identifying the risk factors for delirium and implementing early prevention strategies.

Objective Analyzing the incidence and risk factors of delirium in trauma intensive care unit patients.

Method This study is a prospective research that focuses on all patients in the trauma intensive care unit of a medical center. Data collection will be conducted through questionnaires and electronic medical records. A total of 200 participants will be conveniently selected for the study. Upon admission to the intensive care unit, each patient will complete a basic information questionnaire, and their medical records will be collected daily until they are discharged from the intensive care unit. The study incorporates various assessment scales including Intensive Care Delirium Screening Checklist (ICDSC), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Acute Physiology and Chronic Health Evaluation II (APACHE-II), Injury Severity Score (ISS), and Malnutrition Universal Screening Tool (MUST). Statistical analysis will be done by using IBM SPSS 24.0 for Windows. Descriptive statistics including mean, standard deviation, and percentages will be used to present demographic information. Logistic regression analysis will be applied to identify the key predictive factors for delirium risk.

Expected outcome and clinical application This study anticipates that the non-modifiable risk factors for trauma intensive care unit patients include age, substance use, chronic diseases, traumatic brain injury, prior surgery, frailty, APACHE II score, ISS, and ASA anesthesia classification. The modifiable risk factors include malnutrition, polypharmacy, electrolyte deficiency, metabolic acidosis, pain, mechanical ventilation, physical restraints, total surgical duration, intraoperative blood loss, and low hemoglobin. By understanding these risk factors, high-risk patients can be identified and preventive measures can be implemented to reduce the occurrence of delirium. Furthermore, addressing modifiable risk factors can help in reducing the risk or severity of delirium.

Study Overview

• Status: Completed
• Conditions: Delirium, Risk Factor
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Taiwan
  • 臺灣
    • Taipei, 臺灣, Taiwan, 110
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who admitted to trauma intensive care unit.

Description

Inclusion Criteria:

• Patients who admitted to trauma intensive care unit.
• Age ≥18.
• Patients who belongs to surgical or trauma subject.

Exclusion Criteria:

• Patients who stay in trauma ICU less than 24hrs.
• Patients who can not communicate with Chinese or Taiwanese.
• Patients who was diagnosed dementia.
• Patients who was evaluated -4 or -5 on Richmond Agitation-Sedation Scale.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium incidence	The incidence of delirium in the trauma ICU.	once per day
Predictors of delirium	The risk factors of delirium in the trauma ICU.(Age, APACHE II, ISS, MUST, 5-mFI, blood exam data...)	once per 2-days

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Actual): May 27, 2024
• Study Completion (Actual): July 22, 2024

Study Registration Dates

• First Submitted: September 10, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 202307121RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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