跳至主要内容
临床试验/NCT07365215
NCT07365215已完成不适用

Pediatric Delirium in Swedish PICUs: Incidence, Risk Factors, and Validation of the Swedish Cornell Assessment of Pediatric Delirium (CAPD) Instrument.

Uppsala University3 个研究点 分布在 1 个国家目标入组 676 人开始时间: 2023年12月1日最近更新:

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

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.)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (3)

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