NL-OMON56664撤回不适用
Markers of Oxidative Stress from Supplemental Oxygen in critically-ill children - MOSSO2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 11（—）
入选标准
- •Main study population:
- •- Age below 24 months
- •- Proven VLRTI
- •- Endotracheal intubation
- •- Mechanical ventilation
- •- Informed consent obtained for the complete study protocol (3 days) of
- •exposure to two different oxygen supplementation protocols on separate days
- •combined with non-invasive exhaled-breath measurements and a single
- •non-endoscopic bronchoalveolar lavage at the final day of study after
- •confirmation of comprehension of the Dutch language
- •Non-infected control population:
- •- Age below 12 years
- •- Endotracheal intubation
- •- Mechanical ventilation
- •- No signs of infection (fever, temperature >38.5 C) and no respiratory
- •symptoms (cough, wheeze, snotty) present at moment of intubation
- •- No reported respiratory symptoms in the last seven days prior to pediatric
- •intensive care unit admission
- •- Informed consent obtained for the partial study protocol (1 day) of exposure
- •to the liberal oxygenation protocol combined with non-invasive exhaled-breath
- •measurements after confirmation of comprehension of the Dutch language
排除标准
- •Main study population:
- •- Age above 24 months
- •- Active infection with SARS-CoV-2
- •- Contra-indication for high flow or low flow oxygen supplementation (e.g.
- •previous bleomycin treatment, carbon monoxide intoxication)
- •- No consent
- •- Receiving HFO
- •- Receiving nitric oxide treatment for pulmonary hypertension
- •- In need for specific oxygen saturation targets based on underlying congenital
- •heart disease
- •Non-infected control population:
- •- Age above 12 years
- •- Proven ongoing pulmonary infection
- •- Symptoms of a present or recent infection (temperature >38.5 C) or
- •respiratory symptoms (cough, wheeze, snotty) in the last seven days prior to
- •pediatric intensive care unit admission.
- •- Contra-indication for high flow oxygen supplementation (e.g. previous
- •bleomycin treatment)
- •- No consent
研究者
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