Use of Compuflo in Pediatric Anesthesia: Monitoring of Injection Pressure of Local Anesthetics in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- injection pressure (injection pressure measured by Compuflo)
研究概览
简要总结
A low injection pressure is one of the safety elements to check the correct position of the needle during regional anesthesia. Subjective assessment of pressure during manual injection of local anesthetic is most commonly used. In adults, the monitoring of the injection pressure has already been evaluated and makes it possible to objectify the pressure of the injection pressure. This is possible thanks to a device named Compuflo. No study has measured injection pressures during a regional anesthesia in children. The main objective is to control the injection pressures exercised in daily clinical practice during pediatric regional anesthesia with the Compuflo. Regional anesthesia will be proposed and explained during the anesthesia consultation. The procedure will be performed according to the habits of the anesthesiologist in charge of the patient. Only the addition of the Local Anesthetic Injection Pressure monitoring (Compuflo) to the needle changes the usual setup.
详细描述
The purpose of this study is to evaluate the usual practice using Compuflo, allowing the continuous measurement of the injection pressure of the local anesthetic at the needle level. On the day of the surgery, an anesthesiologist "operator" will realize the echo-guided regional anesthesia, qualifying aloud every injection realized (site or compartment of injection, and volume injected). An "observer" anesthesiologist will note the demographic data (age and weight), then the material data (minimum stimulation intensity, type and size of needles and syringes used), and finally he will note the maximum pressure levels reached during the injections performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minor patient (0-16 years old) with consent of the major legal representative
- •Affiliated to the social security
- •Informed written consent, notification on the anesthesia sheet
排除标准
- •Patient over 16 years old
- •Patient under tutorship / curatorship
- •Young girl with known or suspected ongoing pregnancy
- •Known allergy to local anesthetics
- •Hemostatic disorder
- •Local infection at the puncture site
结局指标
主要结局
injection pressure (injection pressure measured by Compuflo)
时间窗: up to 24 hours (during the ALR)
injection pressure measured by Compuflo
次要结局
- Pressure values compared to the threshold value used in adults of 15 Psi(up to 24 hours (during the ALR))
- Number and ratio of secondary paresthesias(up to 24 hours (during the ALR))
- Pressure values in the different infiltrated compartments(up to 24 hours (during the ALR))
- Pressure values according to the different types of material used(up to 24 hours (during the ALR))
- Pressure values according to the age of the child(up to 24 hours (during the ALR))
- Number and ratio of involuntary intra-neural injections(up to 24 hours (during the ALR))