Current Practice of Patients Undergoing C-arm Procedures at the Operating Department
Baseline Study on Current Practice of Patients Undergoing C-arm Procedures of Extremities or Spinal Cord at the Operating Department of the Maastricht University Medical Center+
All x-ray systems at the MUMC+ are currently operated by radiodiagnostic technicians. This is also the case for C-arms used during surgical procedures at the OR-complex. Because a gain in time efficiency is expected (i.e. not for research related reasons), a group of OR-personnel will be in-house trained to qualify for operating C-arms in low complex procedures. The shift towards C-arm procedures performed by OR personnel has been initiated also in other hospitals as it is expected to be time saving without loss of quality. However, this is an assumption and not proven by any scientific evidence. Several aspects are interesting for scientific studies as little is known about the effects of this shift on image quality, radiation dose, time efficiency and to guarantee that there is no loss of quality for the patient.
This study investigates the standard care, where radiodiagnostic technician operate the C-arms.
This study is set up such that it can serve as a baseline for a future study in which it will be assessed whether the quality of care when OR-personnel operates the C-arms is non-inferior to the standard care.
The aim of the study is to prospectively assess the standard care.
Research questions are twofold:
- What is the current practice and current time efficiency of C-arm procedures performed by radiodiagnostic technicians?
- What is the current quality of C-arm procedures operated by radiodiagnostic technicians?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
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:
- All C-arm OR-procedures performed at the OR-complex of the MUMC+;
- Type of procedure is: low complex: extremities (upper or lower), high complex: lower extremities, spinal cord (four procedure types).
Exclusion Criteria:
- No informed consent;
- Incomplete procedure information and technical parameters;
- Withdrawal of informed consent by the study patient.
Plan de estudios
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Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Gross and nett OR time [minutes]
Periodo de tiempo: 1 day
|
Measures for time efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Radiation dose (DAP[Gycm2])
Periodo de tiempo: 1 day
|
Measure for quality
|
1 day
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time spent by and type of personnel involved [minutes, predefined role]
Periodo de tiempo: 1 day
|
Measure for efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Amount of time spent inefficiently [minutes]
Periodo de tiempo: 1 day
|
Measure for efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Occupancy time C-arm [minutes]
Periodo de tiempo: 1 day
|
Measure for efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Downtime (technical failures) [minutes]
Periodo de tiempo: 1 day
|
Measure for efficiency, recorded by assistent investigator during research period
|
1 day
|
|
Number of revision surgeries
Periodo de tiempo: 1 month
|
Measure for quality, recorded by assistent investigator 1 month after the procedure
|
1 month
|
|
Radiation dose (Dose in ref_point [mGy])
Periodo de tiempo: 1 day
|
Measure for quality, obtained from C-arm
|
1 day
|
|
Image quality subjective scoring
Periodo de tiempo: 1 day
|
Measure for quality, questionaire, Likert scale 1-5 (5 being highest quality)
|
1 day
|
|
Number and type of help requests
Periodo de tiempo: 1 day
|
Measure of quality and efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Collimation [cm2]
Periodo de tiempo: 1 day
|
Measure for quality, obtained from the C-arm (= used field size)
|
1 day
|
|
Radiation related procedure time (beam on, fluoroscopy and acquisition time) [seconds]
Periodo de tiempo: 1 day
|
Measure for quality, obtained from the C-arm
|
1 day
|
|
Number and types of events
Periodo de tiempo: 1 day
|
Measure for quality, obtained from the C-arm
|
1 day
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- NL.MUMC.ORCarms
Plan de datos de participantes individuales (IPD)
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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.
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