- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04541446
Study Dynamic Haptic Robotic Trainer (DHRT) and DHRT+ for Central Venous Catheterization Insertion Training for Residents
외과 레지던트를 위한 CVC 삽입 훈련을 위한 DHRT(Dynamic Haptic Robotic Trainer) 및 DHRT+ 연구
Human participants will include medical residents. Each year, the entering first-year medical residents at Milton S. Hershey Medical Center and Cedars-Sinai Medical Center will be taught to perform central venous catheterization using the Dynamic Haptic Robotic Trainer (DHRT) or the Advanced Dynamic Haptic Robotic Trainer (DHRT+). The resident's performance will be measured and evaluated by these devices during training. The technique of the training does not differ from what is currently taught at either institution. Residents will be required to pass the same skills assessment currently required at their institution. Upon successfully passing the skills assessment, residents will perform central venous catheterization procedures under supervision. The investigators will examine patient files at Milton S. Hershey Medical Center to determine changes in central line-related complication and infection rates associated with the introduction of these training devices.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Pennsylvania
-
Hershey, Pennsylvania, 미국, 17033
- Hershey Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
First-year resident undergoing central venous catheterization training at Milton S. Hershey Medical Center or Cedars-Sinai Medical Center, at least 18 years of age
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Residents to receive Dynamic Haptic Robotic Training
First-year residents at Milton S. Hershey Medical Center or Cedars Sinai Medical Center trained using the Dynamic Haptic Robotic Trainer (DHRT), a device that trains residents to safely perform the needle insertion component of central venous catheterization." |
Device trains medical residents to safely perform the needle insertion portion of Central Venous Catheterization. |
|
실험적: Residents to receive Advanced Dynamic Haptic Robotic Training
First-year residents at Milton S. Hershey Medical Center or Cedars Sinai Medical Center trained using the Advanced Dynamic Haptic Robotic Trainer (DHRT+), which offers whole-procedure training. |
Device offers whole procedural training for medical residents to safely perform the procedure of Central Venous Catheterization. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Internal Jugular Central Venous Catheters With and Without Mechanical Complication
기간: Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
|
Mechanical complications were defined as a composite outcome including hematoma, arterial puncture, pneumothorax, hemothorax, catheter misplacement, and vessel stenosis, identified using diagnosis codes from the International Classification of Diseases that were flagged as not present at the time of hospital admission. Outcome data reflects retrospective chart review at Milton S. Hershey Medical Center. DHRT deployment began June 2021; DHRT+ began June 2022. Data collection is complete. |
Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
|
|
Number of Internal Jugular Central Venous Catheters With and Without Thrombotic Complication
기간: Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
|
Thrombotic complications were defined as venous or arterial thrombosis, including catheter-associated device thrombosis, identified using diagnosis codes from the International Classification of Diseases that were flagged as not present at the time of hospital admission. Outcome data reflects retrospective chart review at Milton S. Hershey Medical Center. DHRT deployment began June 2021; DHRT+ began June 2022. Data collection is complete. |
Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
|
|
Number of Internal Jugular Central Venous Catheters With and Without Infectious Complication
기간: Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
|
Infectious complications were defined as a composite outcome including catheter-site infection and central line-associated bloodstream infection, identified using diagnosis codes from the International Classification of Diseases that were flagged as not present at the time of hospital admission. Outcome data reflects retrospective chart review at Milton S. Hershey Medical Center. DHRT deployment began June 2021; DHRT+ began June 2022. Data collection is complete. |
Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Scarlett R Miller, Ph.D., Penn State University
- 수석 연구원: Jason Z. Moore, Ph.D., Penn State University
- 연구 책임자: Sanaz Motamedi, PhD, Penn State University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- STUDY00012206
- R01HL127316 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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