ACTRN12621001678886已完成未知
asal High Flow in Children post Extubation - a randomised controlled trial (Pilot phase study)
Gold Coast Hospital and Health Services0 个研究点目标入组 91 人开始时间: 2021年12月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 91
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- Days 至 16 Years(—)
- 性别
- All
入选标准
- •Inclusion Criteria for Moderate Reintubation Risk Group (MRRG)- General ICU study
- •All children less than 16 years of age with parental consent and one or both of the following:
- •length of mechanical ventilation equal or more than 4 days
- •oxygen requirement (FiO2 equal or more than 0.4) at extubation
- •Inclusion Criteria for Moderate Reintubation Risk Group (MRRG) - Cardiac ICU study
- •All children less than 16 years of age with parental consent and one or more of the following:
- •RACHS equal or less than4
- •all neonates post cardio-pulmonary bypass and age equal or less than 42 days (post cardiac surgery patients only) belong into MRRG
- •oxygen requirement (FiO2 equal or more than 0.4) at extubation
- •Inclusion Criteria for Low Reintubation Risk Group (LRRG) – General ICU AND Cardiac ICU studies
- •All children less than 16 years of age with parental consent, who fail standard oxygen therapy and require escalation of respiratory support within the first 72 hours post extubation and one or more of the following:
- •all children who do not meet either the inclusion criteria for the moderate-risk reintubation group or meet one of the exclusion criteria
- •length of mechanical ventilation less than 4 days
- •oxygen requirement prior at extubation (FiO2 less than 0.4)
排除标准
- •Excluded are children who require a specific respiratory support (high-risk) or are excluded with the following conditions:
- •Severe cardiac failure
- •Child on home respiratory support
- •Craniofacial abnormalities preventing the use of NHF or CPAP
- •Underlying pathology requiring CPAP or BIPAP such as severe tracheomalacia or bronchomalacia
- •Upper gastrointestinal surgery where positive airway pressure is contraindicated
- •Acknowledged and agreed limitations to care (e.g., do not intubate or resuscitate) or death imminent
- •Mid-facial fracture
- •Previously recruited in the same trial during the same ICU admission
- •RACHS 5 and 6
- •Neuromuscular conditions
- •Choanal atresia/severe choanal stenosis
- •Anatomical or acquired airway conditions with a specific airway and respiratory management protocol
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