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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Leicestershire
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Leicester, Leicestershire, Royaume-Uni, LE1 5WW
- University Hospitals of Leicester
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Volontaires en bonne santé
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Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
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État septique
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Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
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Severe sepsis/septic shock
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Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Measure the extent of thermally apparent mottling of the anterior knee using a previously described mottling score.
Délai: 18 months
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Measure the extent of mottling (graded from 1 to 5) using the mottling score described by Ait-Oufella et al.
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18 months
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Measure core-peripheral temperature difference by means of a facial thermal image (Thermal Core-Peripheral Temperature Difference - TCPTD).
Délai: 18 months
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Thermal core-peripheral temperature difference (TCPTD) will be assessed using temperature at the medial canthus (core) and nasal (peripheral) in degrees centigrade.
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18 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Association between the severity of thermally derived mottling score and the Sequential Organ Failure Assessment (SOFA) score.
Délai: 18 months
|
Association between mottling score (graded 1-5) and illness severity as determined by the SOFA score (0-24).
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18 months
|
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Association between the severity of thermally derived mottling score and the APACHE II score.
Délai: 18 months
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Association between mottling score (1-5) and illness severity as determined by the APACHE II score (0-71).
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18 months
|
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Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the SOFA score.
Délai: 18 months
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Associations between TCPTD (degrees centigrade) and illness severity as determined by the SOFA score (0-24).
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18 months
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Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the APACHE II score.
Délai: 18 months
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Associations between TCPTD (degrees centigrade) and illness severity as determined by the APACHE II score (0-71).
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18 months
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Mortality at 30 days and 1 year from the point of enrollment.
Délai: 18 months
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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.
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18 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jonathan Thompson, MB ChB, BSc, MD, University Hospitals, Leicester
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- UHL 11486
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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