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:
相关药物
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
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