跳至主要内容
临床试验/NCT07038850
NCT07038850已完成不适用

Improving Caregivers' Adherence to a Sedation-analgesia Protocol Managed by Pediatric Intensive Care Nurses: a Quality Approach Program

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2020年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
285
试验地点
2
主要终点
Protocol adherence before and after nurse training: daily percentage of therapeutic adjustments in compliance with the sedation-analgesia protocol.

研究概览

简要总结

Sedation-analgesia is a major concern in the management of children in pediatric intensive care units (PICUs). International guidelines recommend the use of sedation-analgesia protocols, as their implementation has already proven effective in pediatrics. However, maintaining their long-term application remains a challenge. Indeed, healthcare teams adherence to these protocols tends to decrease over time, thereby compromising their long-term impact. This study aims to evaluate the impact of multimodal nurses training on improving and sustaining adherence to sedation-analgesia protocols. This is a non-randomized, before-and-after interventional prospective study conducted in two mixed pediatric intensive care units (Lyon and Nantes). The investigators seek to evaluate sedation practices before and after the implementation of specific multimodal training for nurses on the sedation-analgesia protocol. The primary outcome is protocol adherence. Secondary outcomes include the duration of mechanical ventilation and PICU stay, the number of daily COMFORT-B score assessments, total medication doses, the incidence of ventilator-associated pneumonia, and a qualitative analysis of non-adherence factors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • •patients aged 0 to 18 years
  • •admitted to the PICU
  • •requiring mechanical ventilation
  • •receiving continuous sedation for more than 24 hour

排除标准

  • •patients requiring mechanical ventilation for more than 15 days
  • •transferred from another unit where sedation had already been initiated
  • •patients under sedation as part of withdrawing and withholding life-sustaining treatment
  • •deceased patients
  • •preexisting tracheostomies

结局指标

主要结局

Protocol adherence before and after nurse training: daily percentage of therapeutic adjustments in compliance with the sedation-analgesia protocol.

时间窗: Compliance of therapeutic adjustments with the sedation-analgesia protocol is evaluated over the entire duration of mechanical ventilation. Daily , from initiation of mechanical ventilation until extubation

Sedation management is considered adequate (when dose increases, decreases, or maintenance are appropriate based on the COMFORT-B score), and inadequate (when adjustments are inappropriate or if the COMFORT-B score is not recorded despite a prescribed target). Cases where no target score is prescribed are excluded from the adherence analysis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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