CTRI/2024/09/073455招募中不适用
High-frequency Oscillatory Ventilation with or without Volume Guarantee in Neonates: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Incidence of hypo or hypercarbia at 1 hour after starting high frequency oscillatory ventilation
研究概览
简要总结
**Research question:**In neonates failing conventional mechanical ventilation and requiring high-frequency oscillatory ventilation as a rescue mode (P), does the addition of volume guarantee with HFOV (I) compared to HFOV alone (C) reduce the incidences of hypo or hypercarbia (O)?
**Research hypothesis:**In neonates failing CMV and requiring HFOV as a rescue mode, the addition of VG with HFOV will reduce the incidences of hypo or hypercarbia.
**Aim of the study:**To determine the efficacy of HFOV with VG in neonates failing CMV and requiring HFOV as a rescue mode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 3.00 Month(s)（—）
- 性别
- All
入选标准
- •Neonates who fail conventional mechanical ventilation and require high-frequency oscillatory ventilation as a rescue mode.
- •CMV failure will be defined as the presence of any of the following
- •Peak positive pressure more than 26 cm H2O
- •Mean airway pressure more than 12 cm H2O
- •Diffuse atelectasis in chest x-ray requiring lung recruitment
- •Refractory respiratory acidosis defined as pCO2 more than 60 mmHg and or pH less than 7.20
- •Air leak syndrome in conventional mechanical ventilation.
排除标准
- •Major congenital malformations.
结局指标
主要结局
Incidence of hypo or hypercarbia at 1 hour after starting high frequency oscillatory ventilation
时间窗: At 1 hour
次要结局
- 1. Incidence of hypo or hypercarbia at 6, and 24 hours after starting HFOV(2. Any incidence of hypo or hypercarbia during HFOV)
研究者
Sriparna Basu
All India Institute of Medical Sciences, Rishikesh
研究点 (1)
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