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Infrared Imaging in Septic Illness

2020年2月10日 更新者:University Hospitals, Leicester

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

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

112

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。

学习地点

    • Leicestershire
      • Leicester、Leicestershire、英国、LE1 5WW
        • University Hospitals of Leicester

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

This study will involve the recruitment of acutely unwell patients from the Emergency Department and Intensive Care Unit areas of the hospital, alongside healthy volunteers.

描述

Inclusion Criteria:

  1. Male or Female, aged 18 years or above.
  2. Healthy volunteers - free from acute illness; will include staff and students at the University of Leicester and UHL, and patient relatives.
  3. 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).
  4. Able (in the Investigators opinion) and willing to comply with all study requirements.

Exclusion Criteria:

  1. Patient refusal
  2. Inability to gain appropriate assent/consent
  3. Children
  4. Prisoners or in police custody
  5. Skin marking likely to preclude image analysis (such as extensive tattoos).

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

  • 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
健康志愿者
Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
败血症
Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
Severe sepsis/septic shock
Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)

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
Measure the extent of thermally apparent mottling of the anterior knee using a previously described mottling score.
大体时间:18 months
Measure the extent of mottling (graded from 1 to 5) using the mottling score described by Ait-Oufella et al.
18 months
Measure core-peripheral temperature difference by means of a facial thermal image (Thermal Core-Peripheral Temperature Difference - TCPTD).
大体时间:18 months
Thermal core-peripheral temperature difference (TCPTD) will be assessed using temperature at the medial canthus (core) and nasal (peripheral) in degrees centigrade.
18 months

次要结果测量

结果测量
措施说明
大体时间
Association between the severity of thermally derived mottling score and the Sequential Organ Failure Assessment (SOFA) score.
大体时间:18 months
Association between mottling score (graded 1-5) and illness severity as determined by the SOFA score (0-24).
18 months
Association between the severity of thermally derived mottling score and the APACHE II score.
大体时间:18 months
Association between mottling score (1-5) and illness severity as determined by the APACHE II score (0-71).
18 months
Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the SOFA score.
大体时间:18 months
Associations between TCPTD (degrees centigrade) and illness severity as determined by the SOFA score (0-24).
18 months
Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the APACHE II score.
大体时间:18 months
Associations between TCPTD (degrees centigrade) and illness severity as determined by the APACHE II score (0-71).
18 months
Mortality at 30 days and 1 year from the point of enrollment.
大体时间:18 months
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.
18 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

  • 首席研究员:Jonathan Thompson, MB ChB, BSc, MD、University Hospitals, Leicester

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

2016年7月1日

初级完成 (实际的)

2019年2月1日

研究完成 (实际的)

2019年2月1日

研究注册日期

首次提交

2016年6月20日

首先提交符合 QC 标准的

2016年8月3日

首次发布 (估计)

2016年8月4日

研究记录更新

最后更新发布 (实际的)

2020年2月11日

上次提交的符合 QC 标准的更新

2020年2月10日

最后验证

2020年2月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • UHL 11486

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

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