The Application of Infrared Thermal Imaging in the Diagnosis and Prognostication of Septic Illness in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Measure the extent of thermally apparent mottling of the anterior knee using a previously described mottling score.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Patient refusal
- •Inability to gain appropriate assent/consent
- •Prisoners or in police custody
- •Skin marking likely to preclude image analysis (such as extensive tattoos).
结局指标
主要结局
Measure the extent of thermally apparent mottling of the anterior knee using a previously described mottling score.
时间窗: 18 months
Measure the extent of mottling (graded from 1 to 5) using the mottling score described by Ait-Oufella et al.
Measure core-peripheral temperature difference by means of a facial thermal image (Thermal Core-Peripheral Temperature Difference - TCPTD).
时间窗: 18 months
Thermal core-peripheral temperature difference (TCPTD) will be assessed using temperature at the medial canthus (core) and nasal (peripheral) in degrees centigrade.
次要结局
- Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the SOFA score.(18 months)
- Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the APACHE II score.(18 months)
- Mortality at 30 days and 1 year from the point of enrollment.(18 months)
- Association between the severity of thermally derived mottling score and the Sequential Organ Failure Assessment (SOFA) score.(18 months)
- Association between the severity of thermally derived mottling score and the APACHE II score.(18 months)