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临床试验/EUCTR2016-003670-40-NL
EUCTR2016-003670-40-NL进行中(未招募)1 期

Pediatric Ards Neuromuscular blockade (PAN) study: Life-threatening acute respiratory failure in children: to breathe or not to breathe spontaneously, that's the question. - PAN study

Beatrix Children's Hospital, University Medical Center Groningen0 个研究点目标入组 178 人开始时间: 2017年12月6日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
178

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • - Informed consent
  • - Age younger than 5 years
  • - Need for invasive mechanical ventilation with PEEP 5 cmH2O
  • - Early moderate – to – severe paediatric acute respiratory distress syndrome originating from any cause: - Acute onset of disease, and - Oxygenation index > 12, and - One or more (bilateral) infiltrates on chest radiograph, and - No evidence of left ventricular failure or fluid overload, and - Within the first 96 hours of PICU admission
  • - Sedation defined by Comfort – B scale between 11 - 17
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 178
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - No informed consent
  • - Known allergy or intolerance to rocuronium
  • - Continuous administration of neuromuscular blockade prior at the time of meeting the criteria for paediatric acute respiratory distress syndrome
  • - Bolus administration of neuromuscular blockade within 1 hour before meeting PARDS criteria
  • - Chronic respiratory failure on home ventilation
  • - Intracranial hypertension
  • - Bone marrow transplantation
  • - Pre-existing pulmonary hypertension
  • - Congenital heart disease with left - to - right shunting
  • - Cyanotic congenital heart disease
  • - Expected duration of mechanical ventilation less than 48 hours
  • - Withdrawal of life–sustaining treatment

研究者

发起方
Beatrix Children's Hospital, University Medical Center Groningen

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