- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05238129
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:
- 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?
연구 개요
상태
정황
연구 유형
등록 (예상)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Gross and nett OR time [minutes]
기간: 1 day
|
Measures for time efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Radiation dose (DAP[Gycm2])
기간: 1 day
|
Measure for quality
|
1 day
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time spent by and type of personnel involved [minutes, predefined role]
기간: 1 day
|
Measure for efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Amount of time spent inefficiently [minutes]
기간: 1 day
|
Measure for efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Occupancy time C-arm [minutes]
기간: 1 day
|
Measure for efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Downtime (technical failures) [minutes]
기간: 1 day
|
Measure for efficiency, recorded by assistent investigator during research period
|
1 day
|
|
Number of revision surgeries
기간: 1 month
|
Measure for quality, recorded by assistent investigator 1 month after the procedure
|
1 month
|
|
Radiation dose (Dose in ref_point [mGy])
기간: 1 day
|
Measure for quality, obtained from C-arm
|
1 day
|
|
Image quality subjective scoring
기간: 1 day
|
Measure for quality, questionaire, Likert scale 1-5 (5 being highest quality)
|
1 day
|
|
Number and type of help requests
기간: 1 day
|
Measure of quality and efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Collimation [cm2]
기간: 1 day
|
Measure for quality, obtained from the C-arm (= used field size)
|
1 day
|
|
Radiation related procedure time (beam on, fluoroscopy and acquisition time) [seconds]
기간: 1 day
|
Measure for quality, obtained from the C-arm
|
1 day
|
|
Number and types of events
기간: 1 day
|
Measure for quality, obtained from the C-arm
|
1 day
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NL.MUMC.ORCarms
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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