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临床试验/NCT05035290
NCT05035290招募中不适用

Negative Pressure Ventilation in Critically Ill Paediatric Patients During Weaning: Prospective Randomized Interventional Trial

Brno University Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Early weaning failure

研究概览

简要总结

Negative pressure ventilation (NPV) represent a unique form of noninvasive ventilation using negative pressure by specialized cuirass, that evolve negative pressure on the front size of chest and partially abdomen and facilitate the spontaneous breathing. The benefit of NPV beside noninvasive application, is the supreme tolerance of the patient (compared to other forms of noninvasive ventilation - mask, helmet), without the negative impact on enteral feeding tolerance and with the possibility of active physiotherapy. NPV could be even combined with oxygentherapy or noninvasive positive pressure ventilation. NPV in paediatric patients after extubation could be associated with reduced incidence of weaning failure.

详细描述

After ethics committee approval and informed consent from legal guardians and fulfilling inclusion criteria, critically ill paediatric patients scheduled for weaning will be randomized (in 1:1 allocation) to NPV (interventional group) or standard approach (without NPV) after extubation. NPV in paediatric patients after extubation could be associated with reduced incidence of weaning failure. The initial setting on NPV will be: negative pressure set to -10cmH2O and will proceed for minimal time of 60 minutes after extubation (will proceed longer in case of good tolerance). In case of hypoxaemia, additional oxygentherapy will be administered according to the patients condition Primary outcome will be defined as postextubation failure incidence at 60 minutes after extubation (defined as need of noninvasive positive pressure ventilation, intubation, or high-flow oxygen therapy) and the overall incidence of weaning failure during initial 24 hour after extubation. The secondary outcome will be the dynamics of blood gases (arterial or capillary blood sample) during initial 60 minutes after extubation (1. extubation, 2. 60 minutes after extubation) and the need of and amount of artificial oxygentherapy (litres of oxygen per minute, pulse oximetry). Another outcome will be the overall cuirass tolerance after 60 minutes and after 24 hours defined by incidence of skin lesions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
1 Month 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • invasive mechanical ventilation
  • informed consent
  • scheduled for weaning

排除标准

  • neuromuscular disorder
  • mechanical ventilation at home (chronic use)
  • less than 24 hours after abdominal or thoracic surgery
  • technical problems with the cuirass - chest drain

结局指标

主要结局

Early weaning failure

时间窗: in 60 minutes after extubation

Incidence of early weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy

Overall weaning failure

时间窗: during 24 hours after extubation

Incidence of weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy

次要结局

  • Overall cuirass tolerance(during 24 hours after extubation)
  • Blood gases trends(during initial 60 minutes after extubation)
  • Early cuirass tolerance(during initial 60 minutes after extubation)
  • Pulse oximetry trend(during initial 60 minutes after extubation)

研究者

发起方
Brno University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Petr Štourač, MD

Clinical Professor

Brno University Hospital

研究点 (2)

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