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临床试验/NCT04954261
NCT04954261撤回不适用

Implementing Delirium Detection in Pediatric Intensive Care Unit Through a French Translation of the CAPD : a French Monocentric Observational Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家开始时间: 2018年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Prevalence of delirium in the PICU population

研究概览

简要总结

The purpose of this study is to introduce delirium detection and try to determine the prevalence of delirium in Pediatric Intensive Care Unit (PICU) using a validated tool : the Cornell Assessment of Pediatric Delirium (CAPD) for every patient twice a day.

详细描述

Delirium is a frequent affection in ICU. In adult population, its prevalence is 20-50% in non intubated patients and 60-80% in patients under invasive ventilation. It is also frequent in paediatric population, but less diagnosed, whereas it can lead to higher duration stay, higher morbidity, traumatic injuries, acute stress, memory losses and post-traumatic stress syndrome. Since 2016, international guidelines recommend to look for delirium in paediatric population in PICU. There are 3 recommended tools to diagnose this affection: psCAM-ICU (6 months-5 years old), pCAM-ICU (5 years old-18 years old) and CAPD (birth-18 years old).

None of these validated tools have been translated in French.

The principal objective is to study the practicability of twice a day detection of delirium in PICU using the CAPD.

Investigators will first used a validation process to translate the CAPD in French, based on the validation method for psychological questionnaires suggested by Vallerand.

Then they will ask the paramedics to evaluate through the CAPD every consecutive patient/12 hours, every day during their stay in PICU, except for those completely unresponsive or under curare. This systematic evaluation will take place for 2 consecutive months.

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

  • Being hospitalized in PICU during the inclusion period
  • Age 0 to 18 years old

排除标准

  • Patient with a state of sedation that does not allow the assessment of a change in the state of consciousness or cognitive functioning (equivalent score Richmond Agitation-Sedation Scale RASS <-3 or COMFORT B <11)
  • Patient or Parental opposition to the observational study

结局指标

主要结局

Prevalence of delirium in the PICU population

时间窗: 2 months

Number of CAPD evaluated \> 9 / total number of CAPD evaluated

次要结局

  • Age(2 months)
  • Sex(2 months)
  • Term of birth(2 months)
  • Diagnosis (motivating hospitalization in intensive care)(2 months)
  • Daily severity score (PELOD 2)(2 months)
  • Applicability of the CAPD by the paramedics(Before inclusion period)
  • Applicability of the CAPD by the paramedics after the 2 months period(2 months)
  • Use of the CAPD by the paramedics(2 months)
  • Duration of hospitalization(2 months)
  • Use of benzodiazepines, ketamine, corticosteroids or opioids(2 months)
  • Prior neurological impairment(2 months)
  • Mechanical ventilation, non invasive ventilation or spontaneous ventilation(2 months)
  • Severity score on arrival (PIM 3)(2 months)
  • Death or survival of the patient(2 months)
  • Mechanical ventilation time(2 months)
  • Presence of parents(2 months)
  • Presence of pain(2 months)
  • withdrawal or not(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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