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

Maastricht University Medical Centre (MUMC)

Status: Unknown

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

Treatments: Other: No intervention - standard care is assessed

Study type: Observational

Funder types: Other

Identifiers

NCT05238129

NL.MUMC.ORCarms

Details and patient eligibility

About

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?

Enrollment: 540 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.