此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Hi-Res IR Thermography for the Diagnosis of Toddler's Fractures

2022年9月8日 更新者:Sheffield Children's NHS Foundation Trust

High Resolution Infrared Thermal Imaging for the Diagnosis of Toddler's Fractures: A Pilot Diagnostic Study

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.

研究概览

详细说明

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.

In this study the IR emission (characterised by heat radiation) from the skin at the site of injury is imaged and analysed to screen for a toddler's fracture. The hypothesis is that the inflammation and blood perfusion in fracture and less severe injuries at the site of injury are distinct, leading to distinct temperature gradients.

Toddler's fracture is characterised as a non-displaced spiral fracture of the tibial shaft in young children, usually between the ages of 9 months to 3 years. However other lower extremity injuries in young children can also have similar clinical appearance to the non-displaced spiral tibial fracture. Toddler's fracture usually results from an indirect innocuous twisting or rotational force applied to the foot and lower leg. The cause could be a stumble or fall or attempts to extricate the foot from between the bars of a crib for example.

Innovations in the use of HRTI in screening toddler's fracture can be beneficial as this could reduce the number of unnecessary x-ray radiographs by filtering out cases where the bone is not fractured. Given that toddler's fracture may not be visible on the radiograph close to the time of the injury's occurrence and a repeat radiograph around 10 days is usually required, earlier identification of a fracture would be beneficial. HRTI may be able to detect a fracture at the index visit, thus allowing directed management.

研究类型

介入性

注册 (预期的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Sheffield、英国、S10 2TH
        • 招聘中
        • Clinical Research Facility, Sheffield Children's Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

9个月 至 5年 (孩子)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Significant pain or discomfort (requiring second line analgesia as defined by ED guidelines)
  • Multiple injuries (not localised to a single lower limb)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Infrared imaging of affected tibia
All eligible children will have infrared imaging undertaken of both affected limb and unaffected limb simultaneously.
High resolution infrared imaging of limb of concern and unaffected limb (control).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Diagnostic probability thresholds for Infrared data (delta-temperature thresholds) for identifying Toddler fractures.
大体时间: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.
12 months

次要结果测量

结果测量
措施说明
大体时间
Effective recruitment strategy
大体时间:12 months

Feasibility of recruitment strategy and conversion rates (% eligible), reasons for non-inclusion/opting out of study (% of eligible).

Attrition rates (%). To inform sample size calculation/feasibility of larger trial.

12 months
Identification of relevant Parent related experience measures
大体时间:12 months
Patient/parent qualitative interviews to determine parent experience of care pathway and relative importance to design of future trial. Unvalidated questionnaire used in interviews for exploratory purposes, as no validated tool exists for this area of care.
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Shammi Ramlakhan、Sheffield Children's NHS Trust

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年2月11日

初级完成 (预期的)

2022年9月30日

研究完成 (预期的)

2022年9月30日

研究注册日期

首次提交

2021年6月4日

首先提交符合 QC 标准的

2022年9月8日

首次发布 (实际的)

2022年9月13日

研究记录更新

最后更新发布 (实际的)

2022年9月13日

上次提交的符合 QC 标准的更新

2022年9月8日

最后验证

2022年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • SCH-2528

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅