The FUNK-FLOW Study - Functional Residual Capacity During Different Levels of High-flow in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in global end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
研究概览
简要总结
Although there is a widespread use of HighFlow therapy around the world, there is still uncertainty about the most appropriate initial HighFlow level after nasal continuous positive airway pressure therapy. Higher levels might produce excessive and harmful intra-alveolar pressures exceeding those reached during nasal continuous positive airway pressure therapy. Low levels may not generate sufficient distending pressures, which may result in a loss of functional residual capacity and an increased risk of respiratory failure. Therefore, the aim of this study is to assess the effect of different HighFlow levels on the functional residual capacity and to compare these findings to the functional residual capacity during nasal continuous positive airway pressure therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 73 Hours 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent by one or both parents or legal guardians as documented by signature
- •30 - 35 weeks postmenstrual age
- •Respiratory support with nCPAP PEEP 5mbar and FiO2 < 0.30
- •> 72 hours old
排除标准
- •Inability of the parents to understand the study concept or procedures due to cognitive or linguistic reasons
- •Congenital malformations adversely affecting lung aeration or pulmonary perfusion (e.g. congenital heart or lung defects)
研究组 & 干预措施
High Flow
Standard HighFlow therapy after weaning from continuous positive airway pressure therapy will be applied on different flow levels. Starting with a flow level of 8l/min, the flow-rates will be changed every 30 minutes subsequently from 8-6-4-2-4-6-8 l/min. Meanwhile, data lung volume changes will be measured using electrical impedance tomography.
干预措施: High Flow (Device)
结局指标
主要结局
Change in global end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
时间窗: 230-minute recording period per patient, 30 minutes on each HF level
Change in global EELI over time using electrical impedance tomography (EIT)
次要结局
- Change in mean ventilation distribution during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)(230-minute recording period per patient, 30 minutes on each HF level)
- Change in mean tidal volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)(230-minute recording period per patient, 30 minutes on each HF level)
- Change in oxygen saturation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)(230-minute recording period per patient, 30 minutes on each HF level)
- Change in number of apnoea that required stimulation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)(230-minute recording period per patient, 30 minutes on each HF level)
- Change in fraction of inspired oxygen during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)(230-minute recording period per patient, 30 minutes on each HF level)
- Change in mean respiratory rate (RR) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)(230-minute recording period per patient, 30 minutes on each HF level)
- Change in mean minute volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)(230-minute recording period per patient, 30 minutes on each HF level)
- Change in mean silent spaces during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)(230-minute recording period per patient, 30 minutes on each HF level)
- Change in regional end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)(230-minute recording period per patient, 30 minutes on each HF level)
- Change in heart rate during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)(230-minute recording period per patient, 30 minutes on each HF level)
- Change in reaching 'failure criteria' to stop HighFlow therapy during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)(230-minute recording period per patient, 30 minutes on each HF level)