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首页> 外文期刊>BMC Pediatrics >Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): A Paediatric Acute Respiratory Intervention Study (PARIS)
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Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): A Paediatric Acute Respiratory Intervention Study (PARIS)

机译：细支气管炎的早期高流量鼻导管治疗，一项前瞻性随机对照试验（方案）：一项儿童急性呼吸道干预研究（PARIS）

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Bronchiolitis imposes the largest health care burden on non-elective paediatric hospital admissions worldwide, with up to 15 % of cases requiring admission to intensive care. A number of previous studies have failed to show benefit of pharmaceutical treatment in respect to length of stay, reduction in PICU admission rates or intubation frequency. The early use of non-invasive respiratory support devices in less intensive scenarios to facilitate earlier respiratory support may have an impact on outcome by avoiding progression of the disease process. High Flow Nasal Cannula (HFNC) therapy has emerged as a new method to provide humidified air flow to deliver a non-invasive form of positive pressure support with titratable oxygen fraction. There is a lack of high-grade evidence on use of HFNC therapy in bronchiolitis. Prospective multi-centre randomised trial comparing standard treatment (standard subnasal oxygen) and High Flow Nasal Cannula therapy in infants with bronchiolitis admitted to 17 hospitals emergency departments and wards in Australia and New Zealand, including 12 non-tertiary regional/metropolitan and 5 tertiary centres. The primary outcome is treatment failure; defined as meeting three out of four pre-specified failure criteria requiring escalation of treatment or higher level of care; i) heart rate remains unchanged or increased compared to admission/enrolment observations, ii) respiratory rate remains unchanged or increased compared to admission/enrolment observations, iii) oxygen requirement in HFNC therapy arm exceeds FiO2?≥?40 % to maintain SpO2?≥?92 % (or ≥94 %) or oxygen requirement in standard subnasal oxygen therapy arm exceeds >2L/min to maintain SpO2?≥?92 % (or ≥94 %), and iv) hospital internal Early Warning Tool calls for medical review and escalation of care. Secondary outcomes include transfer to tertiary institution, admission to intensive care, length of stay, length of oxygen treatment, need for non-invasive/invasive ventilation, intubation, adverse events, and cost. This large multicenter randomised trial will allow the definitive assessment of the efficacy of HFNC therapy as compared to standard subnasal oxygen in the treatment of bronchiolitis. The trial is registered with the Australian and New Zealand Clinical Trials Registry ACTRN12613000388718 (registered on 10 April 2013).
机译：毛细支气管炎给全球非择期儿科医院的住院带来最大的医疗负担，多达15％的病例需要接受重症监护。许多先前的研究未能显示药物治疗在住院时间，降低PICU入院率或插管频率方面的益处。在强度较低的情况下尽早使用无创呼吸支持设备以促进早期呼吸支持可能会通过避免疾病进程的进展而影响预后。高流量鼻插管（HFNC）治疗已成为一种新方法，可提供加湿的气流以提供无创形式的可滴定氧气含量的正压支持。缺乏在细支气管炎中使用HFNC治疗的高级证据。在澳大利亚和新西兰的17家医院急诊科和病房（包括12个非三级地区/大城市和5个三级中心）入院的细支气管炎婴儿中比较标准治疗（标准鼻下氧气）和高流量鼻导管治疗的前瞻性多中心随机试验。主要结果是治疗失败。被定义为满足四个预先指定的失败标准中的三个，需要提高治疗水平或更高水平的护理; i）与入院/入院观察相比，心率保持不变或增加; ii）与入院/入院观察相比，呼吸频率保持不变或增加; iii）HFNC治疗组的氧需求超过FiO2≥≥40％以维持SpO2≥标准鼻下氧气治疗臂中的≥92％（或≥94％）或需氧量超过> 2L / min以维持SpO2≥≥92％（或≥94％），并且iv）医院内部的早期预警工具要求进行医疗复查和护理升级。次要结局包括转入大专院校，接受重症监护，住院时间，氧气治疗时间，无创/有创通气需求，插管，不良事件和费用。这项大型的多中心随机试验将对HFNC治疗与标准鼻下氧气治疗细支气管炎的疗效进行明确评估。该试验已在澳大利亚和新西兰临床试验注册中心ACTRN12613000388718（于2013年4月10日注册）注册。

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