Current Practice of Patients Undergoing C-arm Procedures at the Operating Department
- Conditions
- Low Complex (Lower & Upper Extremities)High Complex (Lower Extremities & Spinal Cord)Types of C-arm Procedures Included
- Registration Number
- NCT05238129
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
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:
1. What is the current practice and current time efficiency of C-arm procedures performed by radiodiagnostic technicians?
2. What is the current quality of C-arm procedures operated by radiodiagnostic technicians?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 540
- 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).
- No informed consent;
- Incomplete procedure information and technical parameters;
- Withdrawal of informed consent by the study patient.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiation dose (DAP[Gycm2]) 1 day Measure for quality
Gross and nett OR time [minutes] 1 day Measures for time efficiency, recorded by assistent investigator during procedure
- Secondary Outcome Measures
Name Time Method Time spent by and type of personnel involved [minutes, predefined role] 1 day Measure for efficiency, recorded by assistent investigator during procedure
Occupancy time C-arm [minutes] 1 day Measure for efficiency, recorded by assistent investigator during procedure
Collimation [cm2] 1 day Measure for quality, obtained from the C-arm (= used field size)
Amount of time spent inefficiently [minutes] 1 day Measure for efficiency, recorded by assistent investigator during procedure
Downtime (technical failures) [minutes] 1 day Measure for efficiency, recorded by assistent investigator during research period
Number of revision surgeries 1 month Measure for quality, recorded by assistent investigator 1 month after the procedure
Number and types of events 1 day Measure for quality, obtained from the C-arm
Radiation dose (Dose in ref_point [mGy]) 1 day Measure for quality, obtained from C-arm
Image quality subjective scoring 1 day Measure for quality, questionaire, Likert scale 1-5 (5 being highest quality)
Number and type of help requests 1 day Measure of quality and efficiency, recorded by assistent investigator during procedure
Radiation related procedure time (beam on, fluoroscopy and acquisition time) [seconds] 1 day Measure for quality, obtained from the C-arm