Infrared Imaging in Septic Illness

Completed

• Conditions: Sepsis
• Interventions: Device: Infrared thermal imaging

• Registration Number: NCT02855671
• Lead Sponsor: University Hospitals, Leicester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-20
• Study Start: 2016-07
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-04
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Infrared thermal imaging	-
Severe sepsis/septic shock	Infrared thermal imaging	-
Sepsis	Infrared thermal imaging	-

Primary Outcome Measures

Name	Time	Method
Measure the extent of thermally apparent mottling of the anterior knee using a previously described mottling score.	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).	18 months	Thermal core-peripheral temperature difference (TCPTD) will be assessed using temperature at the medial canthus (core) and nasal (peripheral) in degrees centigrade.

Secondary Outcome Measures

Name	Time	Method
Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the SOFA score.	18 months	Associations between TCPTD (degrees centigrade) and illness severity as determined by the SOFA score (0-24).
Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the APACHE II score.	18 months	Associations between TCPTD (degrees centigrade) and illness severity as determined by the APACHE II score (0-71).
Mortality at 30 days and 1 year from the point of enrollment.	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.
Association between the severity of thermally derived mottling score and the Sequential Organ Failure Assessment (SOFA) score.	18 months	Association between mottling score (graded 1-5) and illness severity as determined by the SOFA score (0-24).
Association between the severity of thermally derived mottling score and the APACHE II score.	18 months	Association between mottling score (1-5) and illness severity as determined by the APACHE II score (0-71).

Trial Locations

Locations (1)

University Hospitals of Leicester; 🇬🇧 Leicester, Leicestershire, United Kingdom