- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04906018
A Study to Collect Imaging Data for the Validation of the Intelligent Ultrasound's ScanNav Anatomy Peripheral Nerve Block (PNB) - US v1.0
연구 개요
상세 설명
Background:
The American Society of Regional Anesthesia and Pain Medicine (ASRA) has published evidence-based assessment of ultrasound-guided regional anesthesia (Neal et al., 2010) concluding that ultrasound guidance is superior or equal to other non-ultrasound nerve localization techniques. A subsequent publication from ASRA (Neal et al., 2016), has strengthened their position of ultrasound guidance being superior than other methods, including for the reduction of local anesthetic systemic toxicity. However, ultrasound-guided regional anesthesia (UGRA) is a difficult technique to master. A key activity of UGRA is ultrasound image interpretation (Sites et al., 2009) which ScanNav Anatomy PNB is designed to support. The data collected during this study will be assessed by a panel of intended users (experts in UGRA) to evaluate the performance and safety of ScanNav Anatomy PNB device highlighting.
Statistical Methodology:
Validation analyses will be conducted once the data collection has been complete. The collected scans will be processed, and the device output will be generated post hoc. Device output will be presented with raw ultrasound side-by-side. A panel of at least three expert anesthesiologists will review and evaluate each processed scan. The majority view of the panel will be used to evaluate each endpoint for any given structure ScanNav Anatomy PNB is intended to highlight.
Data collection and scan processing:
40 different subjects will be scanned. The dataset will be balanced to contain approximately equal numbers of subjects with BMI<30 and BMI>= 30 kg/m2.
All data collection will be performed with FDA cleared general purpose ultrasound machine, ScanNav Anatomy PNB device will not be used during data collection.
Data characteristics for scan subjects (e.g., age and BMI) will be reported. Ultrasound scans for all 9 supported anatomical regions will be collected from both sides of each subject.
90 x 10s clips per supported anatomical region will be generated, consisting of:
- 80 x 10s scene clips: the block view (chosen by the expert scanner) together with the preceding 10 seconds of ultrasound scanning will be recorded (without the use of ScanNav Anatomy PNB)
- 10 x 10s non-scene clips: 10 second ultrasound scans will be recorded at non-optimum block views, chosen by the expert scanner to represent plausible scanning errors (without the use of ScanNav Anatomy PNB) Scenes and non-scenes will be analyzed separately. Unmodified ultrasound video and highlighted video (color overlay produced by ScanNav Anatomy PNB generated post-hoc) will be presented side-by-side to independent experts for data analysis.
Data analysis:
Every clip will be presented to a minimum of 3 independent expert reviewers. All clips from a single anatomical region will be reviewed by the same 3 reviewers. Experts may review more than one anatomical region, but not necessarily all anatomical regions. Thus, a range of experts will review all anatomical regions.
Reviewers will be asked structured questions to assess the highlighting of safety critical anatomical structures (see definitions later in document) and the performance of ScanNav Anatomy PNB output for each individual clip.
The majority opinion (at least 2/3) will be obtained to establish the overall panel opinion (e.g., yes/yes/no = yes) for each structure on each clip.
Data will be evaluated and presented by structure in each anatomical region and overall (i.e., total for each class; nerve, artery etc.).
Inter-rater agreement between the reviewers will be reported on an anatomical region basis.
Data will be presented as frequencies and presented as percent of total clips analyzed.
Data analysis will include stratification by subject age, BMI, and ultrasound machine to ensure consistency across these variables.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health & Science University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Male or female, at least 18 years of age;
- Able to comprehend and sign the Informed Consent prior to enrolment in the study.
- Vaccinated against SARS-CoV-2
Exclusion Criteria:
- Aged <18 years of age;
- Unwilling or unable to provide informed consent.
- BMI> 39 kg/m2
- Known pathology of the area to be scanned
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
volunteer group - BMI less than 30
Each subject with a BMI less than 30 will be randomly allocated to an ultrasound machine and an expert scanner who will perform the ultrasound scans of all supported anatomical regions.
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Each subject will be randomly allocated to an ultrasound machine and an expert scanner who will perform the ultrasound scans of all supported anatomical regions.
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volunteer group - BMI of 30 and above
Each subject with a BMI of 30 and above will be randomly allocated to an ultrasound machine and an expert scanner who will perform the ultrasound scans of all supported anatomical regions.
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Each subject will be randomly allocated to an ultrasound machine and an expert scanner who will perform the ultrasound scans of all supported anatomical regions.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
ScanNav Anatomy PNB highlighting misidentification of structures
기간: 6 months
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Frequency of misidentification of structures [% of total, per anatomical region]
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
ScanNav Anatomy PNB highlighting identification of structures
기간: 6 months
|
Frequency of correct identification of structures [% of total] and Frequency of non-identification of structures [% of total]
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6 months
|
ScanNav Anatomy PNB safety issues
기간: 6 months
|
Frequency of safety issues [% of total]
|
6 months
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ScanNav Anatomy PNB adverse events
기간: 6 months
|
Frequency of highlighting risking an adverse event [% of total]
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6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Glenn Woodworth, MD, Oregon Health and Science University
- 수석 연구원: James Bowness, MD, University of Oxford & Royal Gwent Hospital
간행물 및 유용한 링크
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
- IU2021_AG_07
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
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Ultrasound scans에 대한 임상 시험
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Academisch Medisch Centrum - Universiteit van Amsterdam...완전한
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Piazza della Vittoria 14 Studio Medico - Ginecologia...모병
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Ajou University School of Medicine종료됨