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临床试验/NCT07821268
NCT07821268尚未招募不适用

Impact of Sedation Practices on Clinical Outcomes Among Mechanically Ventilated Pediatric Intensive Care Unit Patients

Yasmine Ahmed Abdelrahman1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
The Richmond Agitation-Sedation Scale (RASS)

研究概览

简要总结

evaluate the impact of sedation adequacy on clinical outcomes in mechanically ventilated children admitted to the pediatric intensive care unit (PICU).

详细描述

evaluate the impact of sedation adequacy on clinical outcomes in mechanically ventilated children admitted to the pediatric intensive care unit (PICU). Sedation is fundamental in the Paediatric Intensive Care Unit (PICU) for mechanically ventilated children, seeking to improve their clinical outcome, enhance ventilator synchronisation, and promote tolerance of invasive procedures. Achieving appropriate sedation is hard, since both under-sedation and over-sedation are linked to negative outcomes, including extended mechanical breathing, heightened risk of ventilator-associated pneumonia

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
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children admitted to PICU requiring invasive mechanical ventilation (MV) ≥ 48 hours and received any form of sedation or analgesia during ventilation ≥ 48 hours.

排除标准

  • - children ventilated after cardiac arrest

研究组 & 干预措施

mechanically ventilated children admitted to the pediatric intensive care unit (PICU).

Children aged between 1 months and 18 years of age

• Children admitted to PICU requiring invasive mechanical ventilation (MV) ≥ 48 hours and received any form of sedation or analgesia during ventilation ≥ 48 hours. (e.g., midazolam 4 (loading dose 0.05-0.1 mg/kg IV and maintenance dose 0.03-0.12 mg/kg/hr IV), fentanyl (loading dose 1-2 mcg/kg IV over 10min and maintenance dose 1-4 mcg/kg/hr IV infusion), ketamine (loading dose 0.5-1 mg/kg IV and maintenance dose 0.1-0.5 mg/kg/hr), morphine (loading dose 0.05-0.1 mg/kg IV and maintenance dose 0.05-0.1 mg/kg IV)

干预措施: no need (Other)

结局指标

主要结局

The Richmond Agitation-Sedation Scale (RASS)

时间窗: 1 year

is a validated 10-point clinical tool used in PICUs to assess patient alertness, agitation, and sedation depth in \<20 seconds. In your sedation-outcome study, nurses score RASS every 4-8 hours to classify adequate sedation (target: RASS -2 to 0) vs. under-sedation (\>0) or over-sedation (≤-3)

次要结局

未报告次要终点

研究者

发起方
Yasmine Ahmed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yasmine Ahmed Abdelrahman

pediatric resident - sohag university

Sohag University

研究点 (1)

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