Infrared Imaging in Septic Illness

NCT02855671 | Completed

• 1 other identifier: UHL 11486
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

microcirculation; thermal; temperature

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• 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

• 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

Study Arms (3)

Healthy volunteers

Device: Infrared thermal imaging

Sepsis

Device: Infrared thermal imaging

Severe sepsis/septic shock

Device: Infrared thermal imaging

Interventions

Infrared thermal imaging DEVICE

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

Healthy volunteers; Sepsis; Severe sepsis/septic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals, Leicester: lead
• Association of Anaesthetists of Great Britain and Ireland: collaborator

Study Sites (1)

University Hospitals of Leicester

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Thompson, MB ChB, BSc, MD

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: August 4, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

GB (1)