Correlation of Standard Loss of Resistance Technique Versus the CompuFlo®-Assisted Technology for Thoracic Epidural Space Identification
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- Percentage of successful thoracic epidural space identification
研究概览
简要总结
The aim of this non inferiority trial is to assess the efficacy of CompuFlo® technology to identify the thoracic epidural space in relation to the gold standard loss of resistance technique.
详细描述
This non inferiority trial shouts to adress whether the CompuFlo® technology to identify the thoracic epidural space is less efficacious to the gold standard loss of resistance technique (LOR). After informed signed consent patients that will be subjected to gynecological operations and meet the inclusion criteria will be eligible to participate. All operations will be performed under general anesthesia and thoracic epidural analgesia regardless of study arm. Patients will be randomly allocated into two study groups. In the first study group (Group LOR) the thoracic epidural space will be identified by the LOR technique and in the second study group (Group C) by the CompuFlo® technology. The primary outcome is the percentage of thoracic epidural space identification success in either study group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Member of the study group that assesses the epidural's success
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Physical Status Classification System I-III Body mass index: 18 -35 kg/m2 Gynecological laparotomy with midline incision under general anesthesia and thoracic epidural analgesia
排除标准
- •Patients' denial to participate in the study ASA Physical Status Classification System >IV Contraindications to epidural analgesia Patients with sepsis Patients with pre-existing neurologic deficits Pre-existing operations in the thoracic spinal cord Emergency operations Patients with end-stage cancer
研究组 & 干预措施
Group LOR
The thoracic epidural space will be identified by the loss of resistance technique.
干预措施: Loss of resistance (LOR) technique (Procedure)
Group C
The thoracic epidural space will be identified by the CompuFlo® technology.
干预措施: CompuFlo® technology (Device)
结局指标
主要结局
Percentage of successful thoracic epidural space identification
时间窗: Loss of sensation to cold 20 min after the first dose administered through the epidural catheter
The success of the thoracic epidural space identification
次要结局
- Percentage of successful thoracic epidural space identification by the first attempt(Loss of sensation to cold 20 min after the first dose administered through the epidural catheter during the first attempt)
- Time to identify the thoracic epidural space(Time to insertion of epidural needle (Tuohy) in the supraspinous ligament to insertion of the epidural catheter)
- Adverse events(From epidural needle insertion up to 72 hours postoperatively)
- Number of attempts to successful thoracic epidural space identification(Number of attempts to successful thoracic epidural space identification up to a maximum of 3 adressed as loss of sensation to cold 20 min after the first dose administered through the epidural catheter)