Clinical trial NCT06048198: Incidence and Predictors of Delirium in the Trauma Intensive Care Unit：Prospective Study
Official title: Incidence and Predictors of Delirium in the Trauma Intensive Care Unit：Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium, Risk Factor
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who admitted to trauma intensive care unit.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Delirium incidence
timeFrame: once per day
measure: Predictors of delirium
timeFrame: once per 2-days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: 臺灣
Study officials:
References: