Current Practice of Patients Undergoing C-arm Procedures at the Operating Department

Study Overview
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Brief Summary
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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?

Official Title
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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+

Conditions
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Types of C-arm Procedures Included, Low Complex (Lower & Upper Extremities), High Complex (Lower Extremities & Spinal Cord)

Intervention / Treatment
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* Other: No intervention - standard care is assessed


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention - standard care is assessed|No intervention - standard care is assessed|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross and nett OR time [minutes] | Measures for time efficiency, recorded by assistent investigator during procedure | 1 day | 
| Radiation dose (DAP[Gycm2]) | Measure for quality | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent by and type of personnel involved [minutes, predefined role] | Measure for efficiency, recorded by assistent investigator during procedure | 1 day | 
| Amount of time spent inefficiently [minutes] | Measure for efficiency, recorded by assistent investigator during procedure | 1 day | 
| Occupancy time C-arm [minutes] | Measure for efficiency, recorded by assistent investigator during procedure | 1 day | 
| Downtime (technical failures) [minutes] | Measure for efficiency, recorded by assistent investigator during research period | 1 day | 
| Number of revision surgeries | Measure for quality, recorded by assistent investigator 1 month after the procedure | 1 month | 
| Radiation dose (Dose in ref_point [mGy]) | Measure for quality, obtained from C-arm | 1 day | 
| Image quality subjective scoring | Measure for quality, questionaire, Likert scale 1-5 (5 being highest quality) | 1 day | 
| Number and type of help requests | Measure of quality and efficiency, recorded by assistent investigator during procedure | 1 day | 
| Collimation [cm2] | Measure for quality, obtained from the C-arm (= used field size) | 1 day | 
| Radiation related procedure time (beam on, fluoroscopy and acquisition time) [seconds] | Measure for quality, obtained from the C-arm | 1 day | 
| Number and types of events | Measure for quality, obtained from the C-arm | 1 day |