Infrared Imaging in Septic Illness

Sepsis Clinical Trial

Official title:

The Application of Infrared Thermal Imaging in the Diagnosis and Prognostication of Septic Illness in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855671
• Other study ID #: UHL 11486
• Status: Completed
• Start date: July 2016
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2020
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Sepsis

Intervention

Device:
• Infrared thermal imaging
Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester	Leicester	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals, Leicester	Association of Anaesthetists of Great Britain and Ireland

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the extent of thermally apparent mottling of the anterior knee using a previously described mottling score.	Measure the extent of mottling (graded from 1 to 5) using the mottling score described by Ait-Oufella et al.	18 months
Primary	Measure core-peripheral temperature difference by means of a facial thermal image (Thermal Core-Peripheral Temperature Difference - TCPTD).	Thermal core-peripheral temperature difference (TCPTD) will be assessed using temperature at the medial canthus (core) and nasal (peripheral) in degrees centigrade.	18 months
Secondary	Association between the severity of thermally derived mottling score and the Sequential Organ Failure Assessment (SOFA) score.	Association between mottling score (graded 1-5) and illness severity as determined by the SOFA score (0-24).	18 months
Secondary	Association between the severity of thermally derived mottling score and the APACHE II score.	Association between mottling score (1-5) and illness severity as determined by the APACHE II score (0-71).	18 months
Secondary	Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the SOFA score.	Associations between TCPTD (degrees centigrade) and illness severity as determined by the SOFA score (0-24).	18 months
Secondary	Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the APACHE II score.	Associations between TCPTD (degrees centigrade) and illness severity as determined by the APACHE II score (0-71).	18 months
Secondary	Mortality at 30 days and 1 year from the point of enrollment.	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