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

NCT ID: NCT05238129

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-02-28

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:

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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention - standard care is assessed

No intervention - standard care is assessed

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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NL.MUMC.ORCarms

Identifier Type: -

Identifier Source: org_study_id

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