ISRCTN60048867已完成未知
FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): a master protocol of two randomised trials to evaluate the non-inferiority of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care
Great Ormond Street Hospital for Children NHS Foundation Trust0 个研究点目标入组 1,200 人开始时间: 2019年6月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 1,200
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32753452/ protocol (added 05/08/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35390113/ Step-down RCT results (added 08/04/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35707984/ Step-up RCT results (added 17/06/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38848138/ Cost-Effectiveness (added 11/06/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Admitted/accepted for admission to PICU/HDU
- •2. Age > 36 weeks corrected gestational age and < 16 years
- •3. Assessed by the treating clinician to require non-invasive respiratory support, EITHER
- •3.1. For an acute illness (step-up RCT) OR
- •3.2. Within 72 hours of extubation following a period of invasive ventilation (step-down RCT)
排除标准
- •Current participant exclusion criteria as of 02/03/2020:
- •1. Assessed by the treating clinician to require immediate intubation and invasive ventilation due to severe hypoxia, acidosis and/or respiratory distress, upper airway obstruction, difficulty managing airway secretions or recurrent apnoeas
- •2. Tracheostomy in place
- •3. Received HFNC/CPAP for > 2 hours in the prior 24 hours
- •4. On home non-invasive ventilation prior to PICU/HDU admission
- •5. Presence of untreated air-leak (pneumothorax and/or pneumomediastinum)
- •6. Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or recent craniofacial surgery
- •7. Agreed ‘not for intubation’ or other limitation of critical care treatment plan in place.
- •8. Previously recruited to the FIRST-ABC trial
- •9. Clinician decision to start other form of non-invasive respiratory support (i.e. not HFNC or CPAP)
- •Previous participant exclusion criteria:
- •1. Assessed by the treating clinician to require immediate intubation and invasive ventilation due to severe hypoxia, acidosis and/or respiratory distress, upper airway obstruction, difficulty managing airway secretions or recurrent apnoeas
- •2. Tracheostomy in place
- •3. Received HFNC/CPAP for > 2 hours in the prior 24 hours
- •4. On home non-invasive ventilation prior to PICU/HDU admission
- •5. Presence of untreated air-leak (pneumothorax and/or pneumomediastinum)
- •6. Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or recent craniofacial surgery
- •7. Agreed ‘not for intubation’ or other limitation of critical care treatment plan in place.
- •8. Previously recruited to the FIRST-ABC trial
研究者
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