跳至主要内容
临床试验/NCT01069185
NCT01069185已完成不适用

Differences in Morbidity Frequency Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning Protocol in Hospital Pablo Tobon Uribe´s Pediatric Intensive Care Unit (PICU). A Randomized Controlled Trial

Hospital Pablo Tobón Uribe1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2010年2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
已完成
发起方
入组人数
92
试验地点
1
主要终点
Primary Composite End Point

研究概览

简要总结

Morbidity frequency associated to a endotracheal suctioning is different between a necessity endotracheal suctioning protocol versus a routine endotracheal protocol.

详细描述

Endotracheal aspiration is a very useful procedure. It has several adverse events every time that aspiration is practiced. This trials wants to identify which protocol (necessity versus routine) could be better to practice in pediatrics intensive care unit with less risk.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Month 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children older than 1 month until 14 years old requiring orotracheal intubation

排除标准

  • High frequency ventilation mode

研究组 & 干预措施

Necessity endotracheal suctioning

Experimental

Endotracheal suctioning depends on clinical manifestations

干预措施: Necessity endotracheal suctioning (Procedure)

Routine endotracheal suctioning

Other

Endotracheal suctioning every two hours

干预措施: Routine endotracheal suctioning (Procedure)

结局指标

主要结局

Primary Composite End Point

时间窗: Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period .

All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician.

次要结局

  • Mechanical Ventilation Length as Days.(Every day while patient really is intubated.)

研究者

发起方
Hospital Pablo Tobón Uribe
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gloria Lema

MD

Hospital Pablo Tobón Uribe

研究点 (1)

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