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临床试验/NCT03673683
NCT03673683已完成不适用

Sedation AND Weaning in Children: the SANDWICH Trial

Queen's University, Belfast34 个研究点 分布在 1 个国家目标入组 10,498 人开始时间: 2018年2月5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
10,498
试验地点
34
主要终点
Duration of Invasive Mechanical Ventilation

研究概览

简要总结

A UK multi-centre cluster randomised controlled trial to determine if a protocol-based intervention incorporating coordinated care with greater nursing involvement to managing sedation and ventilator weaning can reduce the duration of invasive mechanical ventilation and is cost effective compared with usual care in children in Pediatric Intensive Care Units.

详细描述

Mechanical ventilation is a common lifesaving therapy, but the longer a child remains on the ventilator, the more risk they have of developing problems. For this reason, getting the child off the ventilator (called weaning) is an important patient outcome. Sedative drugs are necessary so the child can tolerate the breathing tube, but too much can make them sleepy and delay coming off the ventilator.

In 2014, visits to 24 Paediatric Intensive Care Units (PICUs) were conducted and it was found that weaning was usually performed by doctors and occasionally senior nurses, but weaning was not always done the same way and, because everyone was not involved, it was often disjointed.

This study will determine if a coordinated approach by doctors and nurses to optimise sedation and weaning using guidelines will: (a) reduce how long patients are on a ventilator without causing any increased risk; (b) reduce the time children spend in a PICU and the hospital; (c) be cost effective in the NHS; and (d) be easily adopted by staff delivering care.

Children receiving ventilation, except those that will never come off a ventilator, will be weaned using the guidelines. Data collection will start in all PICUs at the same time from the very beginning of the study when they are weaning children according to usual practice. Each month, one unit will be chosen at random and staff will be trained to use the new guidelines. The unit will continue using the new guidelines for the rest of the trial. Outcome data collected before (usual care) and after (intervention) training will be compared. An evaluation of the process of implementing the new intervention will be undertaken. During the process evaluation, study staff will be interviewed about their experiences and views with the new approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All children (> 16 year old) in participating PICUs receiving invasive mechanical ventilation

排除标准

  • Children who would not reach the primary endpoint (tracheostomy in situ; not expected to survive; treatment withdrawal)
  • Children who are pregnant, as documented in their medical notes

结局指标

主要结局

Duration of Invasive Mechanical Ventilation

时间窗: From admission until 48 hours following extubation

Duration of Invasive Mechanical Ventilation measured in hours from initiation of invasive mechanical ventilation until the first successful extubation

次要结局

  • Non-invasive mechanical ventilation Incidence(From admission up to 90 days or PICU discharge whichever is earlier)
  • Non-invasive mechanical ventilation Duration(From admission up to 90 days or PICU discharge whichever is earlier)
  • Tracheostomy insertion(From admission up to 90 days or PICU discharge whichever is earlier)
  • Successful Extubation(48 hours following extubation)
  • Post-extubation stridor(From admission up to 90 days or PICU discharge whichever is earlier)
  • ICU Mortality(From admission up to 90 days or PICU discharge whichever is earlier)
  • Cost per respiratory complication avoided(28 days)
  • Number of unplanned extubations(From admission up to 90 days or PICU discharge whichever is earlier)
  • Total duration of Invasive mechanical ventilation(From admission up to 90 days or PICU discharge whichever is earlier)
  • PICU length of stay(From admission up to 90 days or PICU discharge whichever is earlier)
  • Hospital length of stay(From admission up to 90 days or PICU discharge whichever is earlier)
  • Number of reintubations(From admission up to 90 days or PICU discharge whichever is earlier)
  • Adverse events(From admission up to 90 days or PICU discharge whichever is earlier)
  • Hospital Mortality(From admission up to 90 days or PICU discharge whichever is earlier)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bronagh Blackwood

Professor

Queen's University, Belfast

研究点 (34)

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