Randomized Controlled Trial Comparing Commonly Used Techniques to Prevent Slippage During Steep Trendelenburg's Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Amount of Patient Movement on the Operating Room Table
研究概览
简要总结
The purpose of this study is to compare two cushioning materials (a gel mattress and an egg-crate foam mattress) placed beneath patients undergoing gynecologic surgery to prevent patients from sliding toward the head of the bed during head-down positioning.
Our hypothesis is that the two materials will be equally good at preventing slide on the table and that slide will be less than 5 cm (<2 inches) on average.
详细描述
Patient undergoing laparoscopic gynecologic surgery are often placed in steep (30 to 45 degrees) Trendelenburg's (head lower than feet) position. This helps the bowels to move towards the patient's head, making surgery in the pelvis safer. During surgery, if patients slide a great deal toward the head of the bed, nerve injury and hernia risk may be increased. Several techniques are in use to prevent patients from sliding on the bed during surgery, and of these, increasing the friction between a patient's skin and the bed surface appears to be the safest technique. Two materials are in use to increase this friction: a gel pad or an egg-crate foam mattress upon which the patient lies with bare skin. This study is comparing these two materials to see which material is associated with the LEAST amount of patient slide. Our hypothesis is that the two materials will be equally good at preventing slide on the table and that slide will be less than 5 cm (<2 inches) on average.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Women undergoing gynecologic laparoscopic or robotic-assisted laparoscopic surgery
- •Trendelenburg's position is planned
- •General anesthesia is planned
排除标准
- •Patients with intolerance of Trendelenburg's position
- •Patients whose surgery are converted to laparotomy
结局指标
主要结局
Amount of Patient Movement on the Operating Room Table
时间窗: About 150 minutes after start of surgery
Patients undergoing gynecologic surgery require steep (30 to 45 degree) Trendelenberg's position to allow adequate exposure of the pelvis. This position leads to a small amount of movement toward the head of the bed. The table was marked at the point of the anterior superior iliac spine (ASIS) and at the point where a vertical marker touching the acromioclavicular (AC) joint of the left shoulder drops to the table. At the end of the surgery, when the operating table is leveled, the final positions of ASIS and AC will be measured. Measurements were made in centimeters to the tenth position.
次要结局
- Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery(postoperative day 1 and postoperative week 3-8)
研究者
Mary Ellen Wechter
Independent Physician
Mayo Clinic