- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03341546
Estimating Patient Size From a Single Radiograph (VocMepAdar)
Validation of a Computational Model to Estimate Patient Anterior-posterior Dimension From an Abdominal Radiograph
A computational model has been created to estimate the abdominal depth of a patient from a single x-ray image. The model has been tested using phantoms and found to be accurate; this study aims to test the accuracy of the model with patients and in a clinical setting.
This will be achieved by enrolling patient's who have already been referred for an anterior-posterior abdomen x-ray examination to the trial, taking a physical measurement of their anterior-posterior abdominal depth and then comparing this measured value with a value as estimated using the computational model based on the patient's x-ray image.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
A non-commercial computational model has been developed in-house to estimate the patient's anterior-posterior or lateral depth using the radiographic image and the known exposure factors with which it was undertaken. This model has been tested using single composition phantoms and found to be accurate. If it was found to be accurate for real clinical examinations, this would automate the measurement of patient size and give institutions the estimate of patient size required for local paediatric patient dose audit. In turn, this would provide the national data required to propose national reference values for paediatric x-ray examinations, which would give all institutions an important comparator for their performance. This would lead to optimisation in those sites most requiring it; nationally, paediatric x-ray imaging would improve in time.
This pilot study is necessary to determine if the computational model is accurate enough to be relied upon. Accuracy will be determined by comparing the estimate made by the computational model for each patient with an actual measurement of the patient's anterior-posterior abdomen depth made at the time of the examination.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Angus
-
Dundee, Angus, Reino Unido, DD1 9SY
- NHS Tayside
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adult
- Referred to Ninewells Hospital for an anterior-posterior abdomen x-ray examination
Exclusion Criteria:
- Patients unable to give consent
- Patients who have had a contrast injection in the previous 24 hours
- Patients suffering abdominal pain at the time of the examination
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Patient cohort
20 patients referred to Ninewells Hospital radiology department for an anterior-posterior abdomen x-ray examination.
All of these patients will have a measurement of their anterior-posterior depth before undergoing their x-ray examination.
An estimate of their anterior-posterior depth will then be made from their x-ray image using the computational model.
|
A single measurement of the patient's anterior-posterior abdominal depth
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Accuracy of the Computational Model
Periodo de tiempo: 2 months
|
The computational model was used to estimate the patient's anterior-posterior abdominal depth using the digital radiographic image, the exposure factors with which it was acquired and a priori knowledge relating to the x-ray unit and digital detector. The outcome measure was the accuracy with which the computational model estimates the patient's anterior-posterior abdominal depth. It was determined by comparing the estimate to measured anterior-posterior abdominal depth (measured at the time of the x-ray examination). Results are expressed as a percentage deviation; a low % deviation is more accurate, a high % deviation less accurate. |
2 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Sarah Vinnicombe, MD, University of Dundee
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2017RA01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .