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?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
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:
- 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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gross and nett OR time [minutes]
Délai: 1 day
|
Measures for time efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Radiation dose (DAP[Gycm2])
Délai: 1 day
|
Measure for quality
|
1 day
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time spent by and type of personnel involved [minutes, predefined role]
Délai: 1 day
|
Measure for efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Amount of time spent inefficiently [minutes]
Délai: 1 day
|
Measure for efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Occupancy time C-arm [minutes]
Délai: 1 day
|
Measure for efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Downtime (technical failures) [minutes]
Délai: 1 day
|
Measure for efficiency, recorded by assistent investigator during research period
|
1 day
|
|
Number of revision surgeries
Délai: 1 month
|
Measure for quality, recorded by assistent investigator 1 month after the procedure
|
1 month
|
|
Radiation dose (Dose in ref_point [mGy])
Délai: 1 day
|
Measure for quality, obtained from C-arm
|
1 day
|
|
Image quality subjective scoring
Délai: 1 day
|
Measure for quality, questionaire, Likert scale 1-5 (5 being highest quality)
|
1 day
|
|
Number and type of help requests
Délai: 1 day
|
Measure of quality and efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Collimation [cm2]
Délai: 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]
Délai: 1 day
|
Measure for quality, obtained from the C-arm
|
1 day
|
|
Number and types of events
Délai: 1 day
|
Measure for quality, obtained from the C-arm
|
1 day
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Autres numéros d'identification d'étude
- NL.MUMC.ORCarms
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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