Clinical trial NCT05238129: Current Practice of Patients Undergoing C-arm Procedures at the Operating Department
Official title: 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+
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Types of C-arm Procedures Included
Low Complex (Lower & Upper Extremities)
High Complex (Lower Extremities & Spinal Cord)
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of consecutive patients who undergo a low complex C-arm procedure (lower or upper extremities) or a high complex C-arm procedure (lower extremities or spinal cord) during the study period at the OR complex of the MUMC+.

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?


Eligibility criteria: 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.

Primary outcomes:
measure: Gross and nett OR time [minutes]
timeFrame: 1 day
measure: Radiation dose (DAP[Gycm2])
timeFrame: 1 day
Secondary outcomes:
measure: Time spent by and type of personnel involved [minutes, predefined role]
timeFrame: 1 day
measure: Amount of time spent inefficiently [minutes]
timeFrame: 1 day
measure: Occupancy time C-arm [minutes]
timeFrame: 1 day
measure: Downtime (technical failures) [minutes]
timeFrame: 1 day
measure: Number of revision surgeries
timeFrame: 1 month
measure: Radiation dose (Dose in ref_point [mGy])
timeFrame: 1 day
measure: Image quality subjective scoring
timeFrame: 1 day
measure: Number and type of help requests
timeFrame: 1 day
measure: Collimation [cm2]
timeFrame: 1 day
measure: Radiation related procedure time (beam on, fluoroscopy and acquisition time) [seconds]
timeFrame: 1 day
measure: Number and types of events
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References: