High Resolution Infrared Thermography as a Diagnostic Aid in Paediatric Wrist Injuries Version 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of Thermal Imaging
研究概览
简要总结
When assessing an injured child, doctors must decide whether or not there is an underlying bony fracture. The current way of doing this is by x-ray. In 2011, 46,000 children attended Sheffield Children's Hospital Emergency Department and 10,400 x-rays were taken - predominately for diagnosis of fractures. For foot and wrist, 2,215 x-rays were 'normal' with no fracture, at a cost of £119,610 (at a tariff of £54 per x-ray). Considering the cost and undesired effect of radiation exposure, a better way to discriminate those patients with fracture is needed. The non-invasive technique of thermal imaging holds promise as a putative technique.
The investigators have earlier demonstrated the potential of thermal imaging for vertebral fractures, diagnosing limp and measuring respiration rate. This study investigates thermal imaging to screen for wrist fractures. The objectives are: (i) accurately identify fracture location, (ii) exclude cases that are sprain and thus reduce the need for their x-ray. The confirmation of a fracture would still require a x-ray. As the study is in collaboration with Sheffield Children's Hospital, only children will be included, however the findings will also be applicable to adults. Thermal imaging is a completely safe and harmless operation, as the camera is non-contact and emits no radiation.
Any trauma, such as a wrist fracture, results in changes in blood flow that in turn affects the skin surface temperature of the skin overlying the injury. These changes affect the amount of emitted infrared radiation and will be recorded and explored to find a marker to differentiate fractures and sprains.
详细描述
Thermal (IR) imaging is based on recording and processing of a part of electromagnetic spectrum below visible light, i.e. infrared band. Objects with a temperature above -273°C (- 459.67°F) emit thermal radiation. In thermography a camera that is sensitive to the mid (3-5 μm) and long (7-14 μm) infrared bands of the electromagnetic spectrum is used. The detection of an injury using thermal imaging relies on underlying physiology of temperature differentials.
Dermal temperature differentials usually do not exceed 0.25°C, while differentials in excess of 0.65°C are consistently related to pathology. Therefore observation of a significant temperature differential is an indication of injury. The use of Infrared for musculoskeletal medical diagnosis and monitoring has been reported in many studies in children and adults.
- Vertebral fractures were detected using thermal imaging • Thermal imaging assisted in diagnosis of the causes of limp including bone fracture.
Thermography has detected a direct correlation between an increase in skin temperature and the existence of anterior) knee pain after implantation of artificial knee joints. It is suggested that thermal imaging is potentially valuable for a rapid, inexpensive and non-invasive diagnosis of pain and inflammation. Infrared spectroscopic analysis has been reported to be is a powerful tool for establishing the material properties that contribute to bone strength and so it thus has been helpful in improving the understanding of the changes in fragile bone.
• The temperature of the bone during drilling could increase above 47oC. This can cause irreversible osteonecrosis. A study used infrared thermal imaging to determine spatial distribution of increase in bone temperature during drilling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
If the thermal imaging is done first, the radiographer taking the x-ray won't be informed of the outcome of the imaging assessment, so two independent assessments can be compared.
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-16 years who are admitted to the Emergency Department of Sheffield Children's Hospital for a wrist injury, and who are x-rayed as part of their standard clinical management. Inclusion is subject to both the patient and carer having read (or being read to in very young children) the information sheets and both the patient and carer consenting to participate.
排除标准
- •Children who have multiple injuries (e.g. those involved in serious car accident accidents).
- •Children who are too distressed (by pain or otherwise).
- •Parents/carers who have difficulty understanding the nature of the study (e.g. non-native English speakers, those with disabilities impairing their understanding of the study etc.) will be excluded.
结局指标
主要结局
Diagnostic accuracy of Thermal Imaging
时间窗: 12 months
Sensitivity and Specificity of thermal imaging in identifying or excluding fractures
The Accuracy of Thermal Imaging to Detect Fractures
时间窗: 12 months
Percentage of fractures correctly identified by Thermal Imaging.
次要结局
未报告次要终点