Non Invasive Ventilation (NIV) Versus Spontaneous Breathing for Preoxygenation During Ear, Nose, and Throat (ENT) Panendoscopy. A Controlled, Prospective, Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- non hypoxemic apnea time
研究概览
简要总结
the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy compared to spontaneous breathing preoxygenation.
the hypothesis is PPV extends the residual functional capacity of lung so it provides more oxygen during apnea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •patient going for scheduled panendoscopy under general anesthesia
排除标准
- •BMI upper to 35 kg/m2
- •pregnancy
- •requirement of jet ventilation
- •tracheostomy
- •acute respiratory failure: pneumonia, pulmonary embolism
- •health insurance careless
研究组 & 干预措施
positive pressure ventilation
Positive Pressure Ventilation with a 4 cmH2O inhale pressure, a positive end-expiratory pressure of 4 cm H2O, a trigger 2, an inspiratory slope of 0, an inhaled oxygen fraction of 100% administered at a 10 L / min flow.
干预措施: positive pressure ventilation (Device)
Oxygenation with simple breathing mask
spontaneously breathing preoxygenation with adapted face mask, to restrict leakage, at 10L/min oxygen, with inhaled fraction of 100% and a 2 L balloon volume.
干预措施: Oxygenation with simple breathing mask (Procedure)
结局指标
主要结局
non hypoxemic apnea time
时间窗: up to 5 minutes after stopping oxygenation
time the oxygen saturation is going down to 90% during apnea
次要结局
- preoxygenation time(up to 10 min after the start of oxygenation)
- surgical laryngoscopy frequency(up to 15 minutes after stopping oxygenation)