Types of C-arm Procedures IncludedNCT05238129
Current Practice of Patients Undergoing C-arm Procedures at the Operating Department
An observational study of Types of C-arm Procedures Included and Low Complex (Lower & Upper Extremities), run by Maastricht University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Types of C-arm Procedures Included, Low Complex (Lower & Upper Extremities), High Complex (Lower Extremities & Spinal Cord)
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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+.
Who may be able to join
- 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).
Who cannot join
- No informed consent;
- Incomplete procedure information and technical parameters;
- Withdrawal of informed consent by the study patient.
About this study
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+
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.
Read more
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?
- Conditions
- Types of C-arm Procedures Included, Low Complex (Lower & Upper Extremities), High Complex (Lower Extremities & Spinal Cord)
- Being tested
- No intervention - standard care is assessed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - standard care is assessedOther
No intervention - standard care is assessed
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross and nett OR time [minutes]
Measures for time efficiency, recorded by assistent investigator during procedure
Measured: 1 day
Radiation dose (DAP[Gycm2])
Measure for quality
Measured: 1 day
Secondary outcomes (11)
Time spent by and type of personnel involved [minutes, predefined role]
Measure for efficiency, recorded by assistent investigator during procedure
Measured: 1 day
Amount of time spent inefficiently [minutes]
Measure for efficiency, recorded by assistent investigator during procedure
Measured: 1 day
Occupancy time C-arm [minutes]
Measure for efficiency, recorded by assistent investigator during procedure
Measured: 1 day
Downtime (technical failures) [minutes]
Measure for efficiency, recorded by assistent investigator during research period
Measured: 1 day
Number of revision surgeries
Measure for quality, recorded by assistent investigator 1 month after the procedure
Measured: 1 month
Radiation dose (Dose in ref_point [mGy])
Measure for quality, obtained from C-arm
Measured: 1 day
Image quality subjective scoring
Measure for quality, questionaire, Likert scale 1-5 (5 being highest quality)
Measured: 1 day
Number and type of help requests
Measure of quality and efficiency, recorded by assistent investigator during procedure
Measured: 1 day
Collimation [cm2]
Measure for quality, obtained from the C-arm (= used field size)
Measured: 1 day
Radiation related procedure time (beam on, fluoroscopy and acquisition time) [seconds]
Measure for quality, obtained from the C-arm
Measured: 1 day
Number and types of events
Measure for quality, obtained from the C-arm
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 May 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Types of C-arm Procedures IncludedStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238129
- Sponsor's protocol ID
- NL.MUMC.ORCarms
- Status last verified
- Apr 2022
- First submitted
- 3 Feb 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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+
- ClinicalTrials.gov ID
- NCT05238129
- Acronym / sponsor ID
- NL.MUMC.ORCarms
- Conditions
- Types of C-arm Procedures Included, Low Complex (Lower & Upper Extremities), High Complex (Lower Extremities & Spinal Cord)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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+.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- No informed consent;
- Incomplete procedure information and technical parameters;
- Withdrawal of informed consent by the study patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - standard care is assessedNo intervention - standard care is assessed | Other | – |
Primary outcome
Gross and nett OR time [minutes]
Time frame: 1 day
Measures for time efficiency, recorded by assistent investigator during procedure
Radiation dose (DAP[Gycm2])
Time frame: 1 day
Measure for quality
11 secondary outcomes
Time spent by and type of personnel involved [minutes, predefined role]
Time frame: 1 day
Amount of time spent inefficiently [minutes]
Time frame: 1 day
Occupancy time C-arm [minutes]
Time frame: 1 day
Downtime (technical failures) [minutes]
Time frame: 1 day
Number of revision surgeries
Time frame: 1 month
Radiation dose (Dose in ref_point [mGy])
Time frame: 1 day
Image quality subjective scoring
Time frame: 1 day
Number and type of help requests
Time frame: 1 day
Collimation [cm2]
Time frame: 1 day
Radiation related procedure time (beam on, fluoroscopy and acquisition time) [seconds]
Time frame: 1 day
Number and types of events
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Types of C-arm Procedures Included and Low Complex (Lower & Upper Extremities), run by Maastricht University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross and nett OR time [minutes] (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.