- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03488849
SureCRIC Standardized Patient Study
SureCRIC is intended to be used as an accessory to cricothyrotomy and tracheotomy devices, helping to identify and stabilize anatomical landmarks for establishing an airway.
Cricothyroid membrane identification accuracy has been reported to be 30-62% in the literature [Bai15, Ell10, Kri15, Lam15]. The current study assesses SureCRIC-assisted medic performance in identifying the cricothyroid membrane in a diverse standardized patient population.
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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District of Columbia
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Washington, District of Columbia, 미국, 20008
- National Center for Human Factors in Healthcare
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Participants (Users):
Inclusion Criteria:
- Paramedic or military combat medic
- Trained to perform a cricothyrotomy
Exclusion Criteria:
- Current or former instructor of cricothyrotomy, airway management, or anatomy
- Experience performing cricothyrotomy on a patient in the last 6 months
- Training on cricothyrotomy in the last 3 months
- Previous or current participation in a study related to cricothyrotomy
- Any condition or physical impairment that limits dexterity and/or tactile feedback
- Performed two or more cricothyrotomies on live humans
- Previous exposure to the SureCRIC
Healthy Volunteers (Standardized Patients):
Inclusion Criteria:
- Less than 10th percentile height female
- 50th percentile height female
- Greater than 90th percentile height female
- Less than 10th percentile height male
- 50th percentile height male
- Greater than 90th percentile height male
Exclusion Criteria:
- Previous exposure to the SureCRIC
- Age under 18 or over 60
- Any skin condition including, but not limited to, eczema and hives
- Skin that is thin, fragile, sensitive and/or prone to redness or irritation including skin that maintains a red, irritated appearance after the light application of pressure
- Easy bruising or use of any blood thinning medication (including aspirin)
- Beard on the neck
- Use of a steroid medication by mouth or in a topical formulation like a cream or ointment
- Any of the following chronic conditions: chronic kidney disease, chronic liver disease, coagulation disorders such as hemophilia or von Willebrand disease, low or dysfunctional platelets (e.g., thrombocytopenia), leukemia, Cushing's syndrome, Ehlers Danlos syndrome, celiac disease, any condition that causes easy bruising or sensitive or fragile skin.
- Previous neck surgery, previous neck trauma, thyroid mass or enlargement, or other neck abnormalities
- Any condition that would make lying supine or without a pillow painful or impossible
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: SureCRIC
SureCRIC-aided cricothyroid membrane identification
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SureCRIC is intended to be used as an accessory to cricothyrotomy and tracheotomy devices, helping to identify and stabilize anatomical landmarks for establishing an airway.
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활성 비교기: Freehand
Freehand cricothyroid membrane identification
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Freehand palpation approach to identification of the cricothyroid membrane
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes
기간: 1 day
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pass/fail assessment for CTM identification as gauged by expert (senior orolaryngologist)
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1 day
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time to Cricothyroid Membrane Identification
기간: 1 day
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time to cricothyroid membrane identification as measured by direct observation
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1 day
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Bair AE, Chima R. The inaccuracy of using landmark techniques for cricothyroid membrane identification: a comparison of three techniques. Acad Emerg Med. 2015 Aug;22(8):908-14. doi: 10.1111/acem.12732. Epub 2015 Jul 21.
- Elliott DS, Baker PA, Scott MR, Birch CW, Thompson JM. Accuracy of surface landmark identification for cannula cricothyroidotomy. Anaesthesia. 2010 Sep;65(9):889-94. doi: 10.1111/j.1365-2044.2010.06425.x. Erratum In: Anaesthesia. 2010 Dec;65(12):1258.
- Kristensen MS, Teoh WH, Rudolph SS, Tvede MF, Hesselfeldt R, Borglum J, Lohse T, Hansen LN. Structured approach to ultrasound-guided identification of the cricothyroid membrane: a randomized comparison with the palpation method in the morbidly obese. Br J Anaesth. 2015 Jun;114(6):1003-4. doi: 10.1093/bja/aev123. No abstract available.
- Lamb A, Zhang J, Hung O, Flemming B, Mullen T, Bissell MB, Arseneau I. Accuracy of identifying the cricothyroid membrane by anesthesia trainees and staff in a Canadian institution. Can J Anaesth. 2015 May;62(5):495-503. doi: 10.1007/s12630-015-0326-y. Epub 2015 Jan 31.
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
키워드
기타 연구 ID 번호
- SureCRIC_SP1
- W81XWH-14-C-0011 (기타 식별자: Defense Health Program)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
기도 폐쇄에 대한 임상 시험
-
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