NCT01891838已完成不适用
Transsphenoidal Surgery for Pituitary Adenomas: Influence of the Ventilation Mode on Intraoperative Bleeding
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- intraoperative bleeding
研究概览
简要总结
The risk of bleeding is important during transsphenoidal surgery. This study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding.
详细描述
The risk of bleeding is important during transsphenoidal surgery. This study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding.
- group Volume controlled ventilation: tidal volume of 7 mL/kg ideal body weight, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Ventilatory frequency is changed if necessary to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg.
- group Pressure-controlled ventilation: initial pressure of 15 cm H2O, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Pressure is modified to maintain a tidal volume of 7 mL/kg of ideal body weight and frequency ventilation is modified to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg.
- In both groups, the fraction of inspired oxygen is 50%. A recruitment maneuver is performed if the blood oxygen saturation became less than 92%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
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
- •Aged > 18 years
- •Patients scheduled for transsphenoidal surgery for pituitary adenomas
排除标准
- •Pregnancy
- •Obesity (BMI> 35)
- •Known respiratory disease
- •Redo surgery
- •Preoperative problem with hemostasis (antiplatelet or anticoagulant treatment; constitutional disorder).
结局指标
主要结局
intraoperative bleeding
时间窗: 1 hour postoperatively
intraoperative bleeding is estimated by the operator (always the same) as minimal (1), low (3), with no significant change in the conduct of the surgical procedure (5) with significant change in the conduct of surgical procedure (7). Intermediate levels are used to rate the levels of intermediate severity.
次要结局
- recruitment maneuver(one hour after surgery)
- generated plateau pressures(one hour after surgery)
- changes of ventilation mode(one hour after surgery)
- arterial desaturation(one hour after surgery)
- realisation of predefined objectives of minute ventilation(one hour after surgery)
- duration of the surgical procedure(one hour after surgery)
- endocrine healing(three months after surgery)
研究者
研究点 (2)
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