Respiratory Critical Care and Anaesthesia Unit, UCL Great Ormond Street Institute of Child Health, London, UK.
Paediatric Intensive Care Unit, Great Ormond Street Hospital, London, UK.
BMJ Open. 2017 Dec 14;7(12):e019253. doi: 10.1136/bmjopen-2017-019253.
Optimal targets for systemic oxygenation in paediatric critical illness are unknown. Observational data indicate that high levels of arterial oxygenation are associated with poor outcomes in resuscitation of the newborn and in adult critical illness. Within paediatric intensive care units (PICUs), staff prevent severe hypoxia wherever possible, but beyond this there is no consensus. Practice varies widely with age, diagnosis, treating doctor and local or national guidelines followed, though peripheral blood oxygen saturations (SpO) of >95% are often targeted. The overall aim of this pilot study is to determine the feasibility of performing a randomised trial in critically ill children comparing current practice of liberal SpO targets with a more conservative target.
Oxy-PICU is a pragmatic, open, pilot randomised controlled trial in infants and children requiring mechanical ventilation and receiving supplemental oxygen for abnormal gas exchange accepted for emergency admission to one of three participating UK PICUs. The study groups will be either a conservative SpO target of 88%-92% (inclusive) or a liberal SpO target of >94%. Infants and children who fulfil all inclusion criteria and none of the exclusion criteria will be randomised 1:1 by a secure web-based system to one of the two groups. Baseline demographics and clinical status will be recorded as well as daily measures of oxygenation and organ support. Discharge outcomes will also be recorded. In addition to observational data, blood and urine samples will be taken to identify biochemical markers of oxidative stress. Outcomes are targeted at assessing study feasibility with a primary outcome of adequate study recruitment (target: 120 participants).
The trial received Health Research Authority approval on 1 June 2017 (16/SC/0617). Study findings will be disseminated in national and international conferences and peer-reviewed journals.
NCT03040570.
儿科危重病患者的全身氧合最佳目标尚不清楚。观察性数据表明，在新生儿复苏和成人危重病中，高动脉氧合水平与不良结局相关。在儿科重症监护病房（PICU）中，工作人员尽可能防止严重缺氧，但除此之外，尚无共识。尽管外周血氧饱和度（SpO）通常目标值为>95%，但由于年龄、诊断、主治医生以及遵循的当地或国家指南的不同，其做法差异很大。本试验性研究的总体目标是确定在危重症儿童中进行随机试验的可行性，该试验比较了目前自由 SpO 目标与更保守目标的治疗效果。
Oxy-PICU 是一项实用的、开放的、试点随机对照试验，纳入需要机械通气并接受补充氧气以纠正异常气体交换的婴儿和儿童，这些儿童因紧急情况而被收入参与研究的三个英国 PICU 之一。研究组将接受以下两种治疗方案之一：保守 SpO 目标为 88%-92%（含）或自由 SpO 目标为>94%。符合所有纳入标准且无任何排除标准的婴儿和儿童将通过安全的基于网络的系统以 1:1 的比例随机分配到两组之一。将记录基线人口统计学和临床状况，以及每日氧合和器官支持的测量结果。还将记录出院结局。除观察性数据外，还将采集血液和尿液样本以鉴定氧化应激的生化标志物。研究结果的目标是评估研究的可行性，主要结局为充分的研究招募（目标：120 名参与者）。
该试验于 2017 年 6 月 1 日获得了英国健康研究局的批准（16/SC/0617）。研究结果将在国家和国际会议以及同行评议的期刊上发表。
NCT03040570。
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