Infrared Imaging in Septic Illness
The Application of Infrared Thermal Imaging in the Diagnosis and Prognostication of Septic Illness in Adults
The application of infrared thermal imaging in the diagnosis and prognostication of septic illness in adults.
During times of severe infection (sepsis), the small blood vessels supplying oxygen and nutrients to the skin and other organs (called the microcirculation), become abnormal and do not function as they normally would in health. Monitoring these small blood vessels is difficult to do clinically and the investigators want to investigate a new way of doing this.
The aim of this study is to validate a novel method of assessing the function of the microcirculation in healthy volunteers and patients with sepsis, by measuring the skin temperature profile of the leg and face with a thermal imaging camera. Thermal imaging cameras measure the heat given off by all objects and represents this as a picture, with colour used to represent the different temperatures.
Patients will be recruited from the Emergency Department and Intensive Care Units at University Hospitals of Leicester in to one of two groups based on their illness severity; uncomplicated sepsis and severe sepsis. Healthy volunteers will be recruited in to a third group. Recruitment will take place over a 6-month period with follow-up lasting for 12-months following recruitment. 105 participants will be recruited in total.
Temperature patterns seen on the face and leg will be investigated between the different groups. Changes in these temperature patterns as patients recover from sepsis (or indeed become worse), will also be investigated. Information from the thermal images will be correlated to routinely measured markers of infection, including clinical measurements (blood pressure, pulse, etc) and routine blood investigations.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Leicestershire
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Leicester、Leicestershire、英国、LE1 5WW
- University Hospitals of Leicester
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Male or Female, aged 18 years or above.
- Healthy volunteers - free from acute illness; will include staff and students at the University of Leicester and UHL, and patient relatives.
- Patient with septic illness will be recruited in to one of two groups depending on their disease severity - Sepsis (without evidence of organ dysfunction) or severe sepsis (with organ dysfunction).
- Able (in the Investigators opinion) and willing to comply with all study requirements.
Exclusion Criteria:
- Patient refusal
- Inability to gain appropriate assent/consent
- Children
- Prisoners or in police custody
- Skin marking likely to preclude image analysis (such as extensive tattoos).
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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健康志愿者
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Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
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败血症
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Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
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Severe sepsis/septic shock
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Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
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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 |
|---|---|---|
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Measure the extent of thermally apparent mottling of the anterior knee using a previously described mottling score.
大体时间:18 months
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Measure the extent of mottling (graded from 1 to 5) using the mottling score described by Ait-Oufella et al.
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18 months
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Measure core-peripheral temperature difference by means of a facial thermal image (Thermal Core-Peripheral Temperature Difference - TCPTD).
大体时间:18 months
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Thermal core-peripheral temperature difference (TCPTD) will be assessed using temperature at the medial canthus (core) and nasal (peripheral) in degrees centigrade.
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18 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Association between the severity of thermally derived mottling score and the Sequential Organ Failure Assessment (SOFA) score.
大体时间:18 months
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Association between mottling score (graded 1-5) and illness severity as determined by the SOFA score (0-24).
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18 months
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Association between the severity of thermally derived mottling score and the APACHE II score.
大体时间:18 months
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Association between mottling score (1-5) and illness severity as determined by the APACHE II score (0-71).
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18 months
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Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the SOFA score.
大体时间:18 months
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Associations between TCPTD (degrees centigrade) and illness severity as determined by the SOFA score (0-24).
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18 months
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Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the APACHE II score.
大体时间:18 months
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Associations between TCPTD (degrees centigrade) and illness severity as determined by the APACHE II score (0-71).
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18 months
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Mortality at 30 days and 1 year from the point of enrollment.
大体时间:18 months
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Mortality information will be collected at 30 days and 1 year from the point of patient enrollment (0-6 months) and correlated to the thermally derived mottling score and thermal core-peripheral temperature difference to assess for potential prognostic value of the above investigations.
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18 months
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合作者和调查者
调查人员
- 首席研究员:Jonathan Thompson, MB ChB, BSc, MD、University Hospitals, Leicester
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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