Pediatric Delirium in Swedish PICUs: Incidence, Risk Factors, and Validation of the Swedish Cornell Assessment of Pediatric Delirium (CAPD) Instrument.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 676
- 试验地点
- 3
- 主要终点
- Incidence of Delirium
研究概览
简要总结
This observational study aims to determine the incidence of delirium among children in a pediatric intensive care unit (PICU) and to identify associated risk factors.
Research Questions:
What is the incidence of delirium among children in a pediatric intensive care unit? What are the identifiable risk factors that predispose children in a pediatric intensive care unit to developing delirium?
详细描述
Study Background and Rationale Delirium, an acute neurocognitive syndrome, is characterized by a sudden onset of fluctuating mental states, reflecting a deterioration in brain function. Its clinical manifestations include impaired attention span, sleep disturbances, acute confusion, impaired concentration, decreased level of consciousness and responsiveness, increased irritability, apathy, or agitation. The duration of delirium can vary from short periods to several days and may fluctuate throughout hospitalization. The presence of delirium can significantly contribute to an increased length of hospital stay and can exacerbate suffering for both the pediatric patient and their family. In Swedish pediatric intensive care units (PICUs), a systematic assessment of delirium using a standardized, validated assessment instrument has historically been absent. This gap in practice hinders the early identification of affected children, which is crucial for improving care and mitigating adverse outcomes. Recognizing this need, an assessment instrument, the Cornell Assessment of Pediatric Delirium (CAPD), has been rigorously translated and culturally adapted from English to Swedish. This study is designed to implement this newly translated instrument to establish the incidence of delirium in children within Swedish PICUs. Furthermore, a critical objective is to identify associated risk factors, which will inform the development and implementation of targeted care strategies aimed at reducing the risk and burden of delirium. The proactive assessment and management of delirium are well-established standard practices in adult intensive care settings, underscoring the imperative for similar advancements in pediatric critical care.
Study Objectives and Research Questions Aim: This observational study aims to determine the incidence of delirium among children in a pediatric intensive care unit (PICU) and to identify associated risk factors.
Research Questions
- What is the incidence of delirium among children in pediatric intensive care units?
- What are the identifiable risk factors that predispose children in a pediatric intensive care unit to developing delirium?
Study Design and Setting This is a prospective, longitudinal multicenter observational study conducted across multiple pediatric intensive care units in Sweden. The study design is optimized for capturing real-world data on delirium incidence and associated factors in a diverse PICU population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected time of care at the pediatric intensive care unit for at least one overnight stay
排除标准
- •Care at the very end of life
结局指标
主要结局
Incidence of Delirium
时间窗: Up to 24 months from PICU admission.
This measure reports the proportion of participants who experience at least one episode of delirium during their pediatric intensive care unit (PICU) stay. Delirium is defined as an acute change in mental status characterized by impaired attention, disorganized thinking, or altered consciousness. Delirium will be determined by daily, once-per-shift assessments using the Cornell Assessment of Pediatric Delirium (CAPD) instrument, a validated bedside screening tool administered by trained nurses. A CAPD score of 9 or higher (on a scale of 0-32, with higher scores indicating greater delirium severity) will be considered indicative of delirium.
次要结局
- Identification of Risk Factors for Delirium(Up to 24 months from PICU admission.)
- Cumulative Duration of Delirium(Up to 24 months from PICU admission.)
- Delirium Subtype Characterization (Hypoactive, Hyperactive, Mixed)(Up to 24 months from PICU admission.)
