Ramnarayan Padmanabhan, Lister Paula, Dominguez Troy, Habibi Parviz, Edmonds Naomi, Canter Ruth, Mouncey Paul, Peters Mark J
Children's Acute Transport Service, Critical Care Division, Great Ormond Street Hospital NHS Foundation Trust, London, UK.
Paediatric Intensive Care Unit, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.
BMJ Open. 2017 Jun 12;7(6):e016181. doi: 10.1136/bmjopen-2017-016181.
Over 18 000 children are admitted annually to UK paediatric intensive care units (PICUs), of whom nearly 75% receive respiratory support (invasive and/or non-invasive). Continuous positive airway pressure (CPAP) has traditionally been used to provide first-line non-invasive respiratory support (NRS) in PICUs; however, high-flow nasal cannula therapy (HFNC), a novel mode of NRS, has recently gained popularity despite the lack of high-quality trial evidence to support its effectiveness. This feasibility study aims to inform the design and conduct of a future definitive randomised clinical trial (RCT) comparing the two modes of respiratory support.
We will conduct a three-centre randomised feasibility study over 12 months. Patients admitted to participating PICUs who satisfy eligibility criteria will be recruited to either group A (primary respiratory failure) or group B (postextubation). Consent will be obtained from parents/guardians prior to randomisation in 'planned' group B, and deferred in emergency situations (group A and 'rescue' group B). Participants will be randomised (1:1) to either CPAP or HFNC using sealed, opaque envelopes, from a computer-generated randomisation sequence with variable block sizes. The study protocol specifies algorithms for the initiation, maintenance and weaning of HFNC and CPAP. The primary outcomes are related to feasibility, including the number of eligible patients in each group, feasibility of randomising >50% of eligible patients and measures of adherence to the treatment protocols. Data will also be collected on patient outcomes (eg, mortality and length of PICU stay) to inform the selection of an appropriate outcome measure in a future RCT. We aim to recruit 120 patients to the study.
Ethical approval was granted by the National Research Ethics Service Committee North East-Tyne&Wear South (15/NE/0296). Study findings will be disseminated through peer-reviewed journals, national and international conferences.
NCT02612415; pre-results.
英国每年有超过18000名儿童被收治入儿科重症监护病房（PICU），其中近75%接受呼吸支持（有创和/或无创）。持续气道正压通气（CPAP）传统上一直用于在PICU中提供一线无创呼吸支持（NRS）；然而，高流量鼻导管治疗（HFNC）作为一种新型的NRS模式，尽管缺乏高质量的试验证据支持其有效性，但最近却越来越受欢迎。这项可行性研究旨在为未来一项比较这两种呼吸支持模式的确定性随机临床试验（RCT）的设计和实施提供信息。
我们将在12个月内进行一项三中心随机可行性研究。符合入选标准的参与PICU收治的患者将被招募到A组（原发性呼吸衰竭）或B组（拔管后）。在“计划”的B组随机分组前将获得父母/监护人的同意，在紧急情况下（A组和“抢救”B组）则推迟同意。使用密封、不透明的信封，根据计算机生成的具有可变区组大小的随机序列将参与者随机（1:1）分配到CPAP或HFNC组。研究方案规定了HFNC和CPAP启动、维持和撤机的算法。主要结局与可行性相关，包括每组符合条件的患者数量、将超过50%符合条件的患者随机分组的可行性以及对治疗方案的依从性测量。还将收集患者结局（如死亡率和PICU住院时间）的数据，以便为未来RCT中选择合适的结局指标提供信息。我们的目标是招募120名患者参与该研究。
获得了国家研究伦理服务委员会东北-泰恩和威尔南部（15/NE/0296）的伦理批准。研究结果将通过同行评审期刊、国内和国际会议进行传播。
NCT02612415；预结果。
