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临床试验/NCT06220825
NCT06220825招募中不适用

PRactice of VENTilation in Critically Ill PEDiatric Patients (PRoVENT-PED) - an International Multicenter Observational Study

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,500
试验地点
1
主要终点
Peak inspiratory pressure

研究概览

简要总结

The goal of this worldwide observational study is to investigate ventilation practice in critically ill pediatric patients. The main questions it aims to answer are:

  1. What is the global current practice of ventilatory support in critically ill pediatric patients?
  2. Which potentially modifiable factors related to ventilation are associated with outcome? Participating pediatric intensive care units will gather detailed information about ventilation practice and outcome, such as duration of ventilatory support, length of ICU stay and ICU mortality.

详细描述

Rationale:

Studies on ventilatory support in critically ill pediatric patients remain scarce and much of the current clinical practice is based upon experience and data originating from critically ill adult patients.

Objectives:

  1. To describe the worldwide practice of ventilatory support in critically ill pediatric patients; and
  2. To identify potentially modifiable ventilation parameters that have independent associations with outcome.

Hypothesis:

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 use of (non-)invasive respiratory support for at least 12 hrs

排除标准

  • premature infants (i.e., postconceptional age corrected for gestational age < 40 weeks)

结局指标

主要结局

Peak inspiratory pressure

时间窗: First four days of (non-)invasive respiratory support

Peak inspiratory pressure

Plateau pressure

时间窗: First four days of (non-)invasive respiratory support

Pateau pressure

Driving pressure

时间窗: First four days of (non-)invasive respiratory support

Driving pressure

Mechanical power

时间窗: First four days of (non-)invasive respiratory support

Mechanical power

Positive end-expiratory pressure

时间窗: First four days of (non-)invasive respiratory support

Positive end-expiratory pressure

Tidal volume

时间窗: First four days of (non-)invasive respiratory support

Tidal volume

次要结局

  • Duration of respiratory support (in days)(Up to 28 days following initiation of (non-)invasive respiratory support)
  • ICU mortality(Up to 28 days following initiation of (non-)invasive respiratory support)
  • Ventilator-free days at day 28(Up to 28 days following initiation of (non-)invasive respiratory support)
  • Length of ICU stay (in days)(PICU admission)
  • PARDS prevalence(First four days of (non-)invasive respiratory support)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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