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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06048198
Collaborator
(none)
200
15.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Incidence and Predictors of Delirium in the Trauma Intensive Care Unit:Prospective Study
Anticipated Study Start Date :
Sep 11, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Outcome Measures

Primary Outcome Measures

  1. Delirium incidence [once per day]

    The incidence of delirium in the trauma ICU.

  2. Predictors of delirium [once per 2-days]

    The risk factors of delirium in the trauma ICU.(Age, APACHE II, ISS, MUST, 5-mFI, blood exam data...)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT06048198
Other Study ID Numbers:
  • 202307121RINC
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023