A Clinical Evaluation Of Infrared Thermography To Assess Successful Caudal Block In Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Predictive value of FLIR ONE
研究概览
简要总结
Regional analgesia via caudal neuraxial blockade provides pain relief for pediatric patients following urological and lower extremity procedures. The injection of local anesthetic into the caudal epidural space causes a sensory loss. This sympathetic blockade in turn causes a vasodilation, or increased blood flow, to the lower extremities.
The purpose of this study is to determine whether the FLIR ONE thermographic camera, a smartphone attachment which utilizes an application ("app") to measure the temperature at a site on an image of the lower extremity, will be able to differentiate between caudal, non-caudal, and failed caudal images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children from 6mos to 5 years of age requiring general anesthesia and a caudal block for a surgical procedure
排除标准
- •Patients with preexisting conditions that could affect the skin temperature on the lower extremities such as infection, edema, vascular disorder, etc.
- •American Society of Anesthesiologists comorbidity ranking of 4 or greater
- •Patient with contraindications for a caudal block such as: history of allergic, reactions to local anesthetics, coagulopathy, infection at the injection site, spinal abnormality, peripheral neurological disease, Raynaud's disease
研究组 & 干预措施
Caudal
Participants receiving a caudal neuraxial blockade, as clinically indicated.
干预措施: FLIR ONE (Device)
Caudal
Participants receiving a caudal neuraxial blockade, as clinically indicated.
干预措施: Regional Anesthesia - Caudal Nerve Block (Procedure)
No Caudal
Participants not receiving a caudal neuraxial blockade, as clinically indicated.
干预措施: FLIR ONE (Device)
结局指标
主要结局
Predictive value of FLIR ONE
时间窗: Assessments will be done through study completion, an average of 1 week following procedure.
Reviewers blinded to intervention groups will asses patient pre-caudal, 1, 2, 3, 4, and 5 minute post-caudal images and rate whether, based on the image, they believe the patient received a caudal or not. The sensitivity and specificity of the FLIR ONE as a diagnositic tol will then be determined.
次要结局
- Inter- and Intra- rater reliability(Assessments will be done through study completion, an average of 1 week following procedure.)
- Temperature differences between pre-caudal and 5 minute post-caudal images(Images will be captured prior to caudal and 5 minutes immediately afterwards. Assessments will be done through study completion, an average of 1 week following procedure.)
研究者
Luis Sequera-Ramos
Resident Physician, Anesthesiology
Ann & Robert H Lurie Children's Hospital of Chicago