NCT01607723已完成3 期
Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Oxygenation in NAVA and in PAV+
研究概览
简要总结
Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between NAVA and PAV+.
详细描述
Twenty patients will be enrolled. They will be ventilated with PAV+ and NAVA for one day, each in a randomized crossover order. The oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated remaining duration of mechanical ventilation for more than two days
- •patient alert and calm
- •Surrogate decision maker's consent
排除标准
- •Clinical contraindication for the use of NAVA: contraindications for an EAdi catheter placement (e.g., esophageal varices, upper gastrointestinal bleeding, gastroesophageal surgery)
- •Clinical instability for any reason
- •Contraindications for continuing intensive care treatment
- •Patient under tutelage
- •Age < 18 years
- •Pregnancy
- •No French health insurance
结局指标
主要结局
Oxygenation in NAVA and in PAV+
时间窗: after one day of ventilation in NAVA and in PAV+
次要结局
- Ventilatory comfort(Every 6 hours in the two ventilatory modes)
- Sleep pattern(During 24h of mechanical ventilation in NAVA and in PAV+)
- Patient-ventilator asynchronies(During the 24h of mechanical ventilation in NAVA and in PAV+)
- Ventilatory parameters(During the 24h of mechanical ventilation in NAVA and in PAV+)
研究者
研究点 (2)
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