Does Less Trendelenburg Make a Difference in Robotic Assisted Gynecological Procedures?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- • Mean Angle of Trendelenburg during surgery (Degrees of the operative head down, measured by electronic angle meter) and the difference in the two arms
研究概览
简要总结
Patient/Population: Women over the age of 18, who are not pregnant and are undergoing benign, robotic-assisted gynecologic procedures at Lutheran General Hospital.
Intervention: Decreasing the angle of Trendelenburg for the procedure Control: Steep Trendelenburg, which is the usual standard of care, to the limit of the operative bed, which is 30 degrees.
Outcome: Outcomes will include the mean angle of Trendelenburg in the experimental arm and the difference in Trendelenburg between the two arms. Additional outcomes included will be end tidal Carbon dioxide, peak airway pressure, mean arterial pressure, heart rate and arterial Carbon dioxide. Secondary outcomes will include operative time, blood loss and conversion to laparotomy.
详细描述
For any patient undergoing robotic-assisted benign laparoscopic procedures at Lutheran General Hospital were eligible to participate. Each subject was randomized to steep or a decreased angle of Trendelenburg. While under anesthesia an arterial line would be placed to monitor vital signs. At specific time points throughout surgery, all vital signs were measured including End Tidal CO2, peak airway pressure, mean arterial pressure, heart rate and arterial CO2 as well as operative time, blood loss and conversion to laparotomy.
The arterial line was removed at the conclusion of the case, and all variables will be compared between the two cohorts.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •all women at Lutheran General Hospital undergoing robotic-assisted benign gynecologic procedures and who agree to participate in the study.
- •Women who are 18 years or older on the day of surgery.
- •Patients with any co-morbidity or prior surgery, as long as they are cleared by their surgeon and anesthesia to undergo robotic-assisted surgery.
排除标准
- •pregnant women
- •Anyone who is less than 18 years old on the day of surgery.
- •Anyone who does not have the capacity to make independent medical decisions.
研究组 & 干预措施
Group A
Steep Trendelenburg
干预措施: Steep Trendelenburg (Procedure)
Group B
Decreased Trendelenburg
干预措施: Decreased Trendelenburg (Procedure)
结局指标
主要结局
• Mean Angle of Trendelenburg during surgery (Degrees of the operative head down, measured by electronic angle meter) and the difference in the two arms
时间窗: 0-240 minutes
Measured using electronic Angle Meter from supine to Trendelenburg in degrees (0-30)
次要结局
- Cardiovascular Outcomes- Mean arterial Pressure(0-240 minutes)
- Cardiovascular Outcomes- Heart rate(0-240 minutes)
- Respiratory Parameter- arterial CO2(0-240 minutes)
- Respiratory Outcomes- End Tidal CO2(0-240 minutes)
- Respiratory Outcomes- Peak Airway Pressure(0-240 minutes)
- Estimated Blood Loss(0-240 minutes)
- Redocking of the robot(0-240 minutes)
- Conversion of surgical approach(0-240 minutes)
- Operative Time(1-240 minutes)