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:

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Types of C-arm Procedures Included; Low Complex (Lower & Upper Extremities); High Complex (Lower Extremities & Spinal Cord)
• Intervention / Treatment: Other: No intervention - standard care is assessed

• Study Type: Observational
• Enrollment (Anticipated): 540

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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+.

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NL.MUMC.ORCarms

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No