Clinical trial NCT02855671: Infrared Imaging in Septic Illness
Official title: The Application of Infrared Thermal Imaging in the Diagnosis and Prognostication of Septic Illness in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: microcirculation
thermal
temperature
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: Association of Anaesthetists of Great Britain and Ireland
First posted: 2016-08-04
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Measure the extent of thermally apparent mottling of the anterior knee using a previously described mottling score.
timeFrame: 18 months
measure: Measure core-peripheral temperature difference by means of a facial thermal image (Thermal Core-Peripheral Temperature Difference - TCPTD).
timeFrame: 18 months
Secondary outcomes:
measure: Association between the severity of thermally derived mottling score and the Sequential Organ Failure Assessment (SOFA) score.
timeFrame: 18 months
measure: Association between the severity of thermally derived mottling score and the APACHE II score.
timeFrame: 18 months
measure: Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the SOFA score.
timeFrame: 18 months
measure: Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the APACHE II score.
timeFrame: 18 months
measure: Mortality at 30 days and 1 year from the point of enrollment.
timeFrame: 18 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
state: Leicestershire
Study officials:
affiliation: University Hospitals, Leicester
name: Jonathan Thompson, MB ChB, BSc, MD
role: PRINCIPAL_INVESTIGATOR
References: