Infrared Imaging in Septic Illness
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.
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.
Visão geral do estudo
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Leicestershire
-
Leicester, Leicestershire, Reino Unido, LE1 5WW
- University Hospitals of Leicester
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Voluntários saudáveis
|
Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
|
|
Sepse
|
Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
|
|
Severe sepsis/septic shock
|
Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Measure the extent of thermally apparent mottling of the anterior knee using a previously described mottling score.
Prazo: 18 months
|
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).
Prazo: 18 months
|
Thermal core-peripheral temperature difference (TCPTD) will be assessed using temperature at the medial canthus (core) and nasal (peripheral) in degrees centigrade.
|
18 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Association between the severity of thermally derived mottling score and the Sequential Organ Failure Assessment (SOFA) score.
Prazo: 18 months
|
Association between mottling score (graded 1-5) and illness severity as determined by the SOFA score (0-24).
|
18 months
|
|
Association between the severity of thermally derived mottling score and the APACHE II score.
Prazo: 18 months
|
Association between mottling score (1-5) and illness severity as determined by the APACHE II score (0-71).
|
18 months
|
|
Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the SOFA score.
Prazo: 18 months
|
Associations between TCPTD (degrees centigrade) and illness severity as determined by the SOFA score (0-24).
|
18 months
|
|
Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the APACHE II score.
Prazo: 18 months
|
Associations between TCPTD (degrees centigrade) and illness severity as determined by the APACHE II score (0-71).
|
18 months
|
|
Mortality at 30 days and 1 year from the point of enrollment.
Prazo: 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.
|
18 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jonathan Thompson, MB ChB, BSc, MD, University Hospitals, Leicester
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- UHL 11486
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .