SepsisNCT02855671
Infrared Imaging in Septic Illness
An observational study of Sepsis, run by University Hospitals, Leicester at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- Infrared thermal imaging
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester
Leicester, Leicestershire, LE1 5WW
About this study
Official title: 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.
Read more
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
- Being tested
- Infrared thermal imaging
- Keywords
- microcirculation, thermal, temperature
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared thermal imagingDevice
Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described Receives: Device: Infrared thermal imaging | |
| Sepsis | Not described Receives: Device: Infrared thermal imaging | |
| Severe sepsis/septic shock | Not described Receives: Device: Infrared thermal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Secondary outcomes (5)
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).
Measured: 18 months
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).
Measured: 18 months
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).
Measured: 18 months
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).
Measured: 18 months
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Association of Anaesthetists of Great Britain and Ireland
- Responsible party
- Sponsor
- Investigators
- Jonathan Thompson, MB ChB, BSc, MD, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855671
- Sponsor's protocol ID
- UHL 11486
- Status last verified
- Feb 2020
- First submitted
- 20 Jun 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Infrared Thermal Imaging in the Diagnosis and Prognostication of Septic Illness in Adults
- ClinicalTrials.gov ID
- NCT02855671
- Acronym / sponsor ID
- UHL 11486
- Conditions
- Sepsis
- Keywords
- microcirculation, thermal, temperature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- Association of Anaesthetists of Great Britain and Ireland
- Study start
- Jul 2016
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Infrared thermal imaging |
| Sepsis | – | Device: Infrared thermal imaging |
| Severe sepsis/septic shock | – | Device: Infrared thermal imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared thermal imagingPatients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee) | Device | Healthy volunteers, Sepsis, Severe sepsis/septic shock |
Primary outcome
Measure the extent of thermally apparent mottling of the anterior knee using a previously described mottling score.
Time frame: 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).
Time frame: 18 months
Thermal core-peripheral temperature difference (TCPTD) will be assessed using temperature at the medial canthus (core) and nasal (peripheral) in degrees centigrade.
5 secondary outcomes
Association between the severity of thermally derived mottling score and the Sequential Organ Failure Assessment (SOFA) score.
Time frame: 18 months
Association between the severity of thermally derived mottling score and the APACHE II score.
Time frame: 18 months
Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the SOFA score.
Time frame: 18 months
Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the APACHE II score.
Time frame: 18 months
Mortality at 30 days and 1 year from the point of enrollment.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Thompson, MB ChB, BSc, MD principal investigator
University Hospitals, Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the extent of thermally apparent mottling of the anterior knee using a previously described mottling score. (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.