High Resolution Infrared Thermal Imaging for the Diagnosis of Toddler's Fractures: A Pilot Diagnostic Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Diagnostic probability thresholds for Infrared data (delta-temperature thresholds) for identifying Toddler fractures.
研究概览
简要总结
This is a pilot proof of feasibility study to explore the efficacy of high resolution thermal imaging (HRTI) to screen for toddler's fractures. In HRTI, a sensitive thermal camera is used to capture the temperature profile of the suspected fracture region and then analyse and interpret the information using image processing.
Toddler's fractures are a common type of tibial fracture in children under 5 years old that can be particularly difficult to detect as the bone typically appears normal on x-ray for the first 10 days and becomes detectable thereafter only as new bone forms. The child's leg is put in plaster in the interim and the diagnosis cannot be confirmed until 10-14 days later. Around 60% of children with suspected toddler's fracture will not have a fracture, and would therefore have had plaster, repeat attendances and repeat x-ray unnecessarily. There is also the inconvenience and general risks of plaster immobilisation for the child. In an earlier study, the investigators demonstrated that HRTI has potential in diagnosing limp in children. This study included two children with toddler's fracture where HRTI detected the fracture's location on the patient's first Emergency Department(ED) visit. In this study, the investigators aim to build on earlier work to explore HRTI for screening for toddler's fracture. On its successful completion, the investigators aim to develop the technology in a follow on larger diagnostic study as a tool that could be used to quickly exclude cases where the injury has not resulted in a fracture. This would allow more objective decision making during the initial assessment of the child. In addition, a reduction in the number of unnecessary x-rays, revisits, treatment as well as cost is anticipated.
详细描述
High resolution thermal imaging (HRTI) imaging is based on recording and processing of a part of electromagnetic spectrum below visible light i.e. infrared (IR) band. Objects with a temperature above -273 °C (-459.7 °F) emit IR (i.e. thermal) radiation. In HRTI a highly sensitive thermal camera that operates to the mid (3-5 μm) and long (7-14 μm) IR bands of the electromagnetic spectrum is used for imaging. The method results in a series of images (capture rate typically 30 frames per second). The images are processed using specialised software to extract and interpret its information. This includes neural networks and similar artificial intelligence models.
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 can be an indication of an injury. The use of infrared HRTI in paediatric for musculoskeletal diagnosis and monitoring as well as physiological measurements have showed potential. Examples of the related studies are:
- Vertebral fractures were detected in osteogenesis imperfecta patients using thermal imaging .
- Thermal imaging assisted in diagnosis of limp, including bone fracture cases
- Thermal imaging showed potential for differentiating between wrist fracture and sprain.
- Thermal imaging could accurately quantify the temperature difference between inflamed and uninflamed knees thus assisting with the diagnosis of juvenile idiopathic arthritis.
- Infrared thermal imaging has proved valuable in detecting inflammatory intra-abdominal pathology in infants.
- Thermal imaging provided effective for measuring respiration rate in a non- contact manner, i.e. no sensing unit attached to the patient's body.
Blood convection warms the skin by transfer of heat from the core and this process plays the major role in determining skin temperature. Skin's has a thermoregulatory role, i.e. it generates, absorbs, conducts and radiates heat. Changes in the skin surface temperature are valuable in detecting physiological and pathological states such as inflammation.
With recent developments in thermal imaging devices, the use of infrared imaging for injury examination is expanding, with more evidence supporting its use. However, the data in children are still limited, with the investigators' research group undertaking significant development work in this field.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 9 months-5 years (inclusive)
- •Clinical suspicion of Toddler's fracture i.e x-rayed as part of their standard clinical management (confirmation of diagnosis).
- •Injury within the preceding 72 hours.
- •Ability to understand written and /or verbal consent and participant information.
排除标准
- •Significant pain or discomfort (requiring second line analgesia as defined by ED guidelines)
- •Multiple injuries (not localised to a single lower limb)
结局指标
主要结局
Diagnostic probability thresholds for Infrared data (delta-temperature thresholds) for identifying Toddler fractures.
时间窗: 12 months
Diagnostic performance (Sensitivity, Specificity) at different thresholds of infrared data measures (measure = delta-temperature; unit = degrees Celsius - as assessed by trained neural networks using temperature data from the high resolution IR camera). Gold standard is clinical diagnosis compared with neural network diagnosis in children with a toddlers fracture.
次要结局
- Effective recruitment strategy(12 months)
- Identification of relevant Parent related experience measures(12 months)