- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03231345
Ultrasound-guided Peripheral IJ Study
Ultrasound-guided Placement of Peripheral Intravenous Lines in the Internal Jugular Vein.
연구 개요
상세 설명
Intravenous access in the emergency department (ED) patient is essential for medication delivery, IV fluid resuscitation, rapid serum laboratory diagnostics, and administration of IV contrast for CT scans. Some patients, such as those with obesity, IV drug abuse, chronic illnesses, or vascular pathology may have difficult IV access. These patients are problematic for the busy ED nurse and physician as this can lead to a time consuming process, which slows efficiency and patient care.
Previously, patients with difficult IV access often required central venous catheterization, a procedure that can result in a number of serious complications (1). More recently, ultrasound guidance has been touted as an effective means to achieve peripheral IV access on these patients (2). In one study (2), there was a 73% first attempt cannulation rate, which seems respectable, but not excellent. Additionally, 8% of the successful IVs failed within one hour (2). Another study compared ultrasonographically guided peripheral IVs to non-ultrasonographically guided IVs, and it found that using ultrasound did not decrease the amount of time or the number of attempts it took to successfully place a peripheral IV (3). Although ultrasound-guided peripheral IV's have a role, there remains room for improvement in being able to achieve rapid IV access in those patients who need IV access on an urgent basis.
It seems that we still have room to improve our ability to obtain difficult IV access, and a relatively new technique may be the answer. Ultrasound guided IVs are typically attempted in the upper extremities, targeting the brachial or basilic veins, but a recently described technique --- the "peripheral IJ" --- involves placement of a peripheral IV catheter in the internal jugular vein (4,5).
The peripheral IJ is gaining popularity in the investigators' ED as a solution to the difficult vascular access patient. In the investigators' clinical experience, it is a quick and easy procedure that is also safe, tolerated well by patients, and requires few resources. Several small studies have concluded that this is a fast and safe procedure and a feasible alternative to central access in the difficult vascular access patient (4-7). These studies mention the theoretical risks as being similar to central venous access such as carotid artery puncture, hematoma, pneumothorax, and line infection, however none of these have actually been reported (4-7). Therefore, we seek primarily to determine the average number of attempts to cannulation for ultrasound-guided peripheral IJ placement. Secondarily, we wish to determine: 1) the prevalence of potential complications related to this procedure 2) the average time it takes the emergency physician to complete the procedure 3) the patient's satisfaction with the procedure. We will compare the data from this study to the published data for other types of ultrasound-guided peripheral IVs.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Nevada
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Las Vegas, Nevada, 미국, 89102
- University Medical Center of Southen Nevada
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- At least 2 unsuccessful attempts at peripheral IV access by ED nursing
- Age 18 or older
Exclusion Criteria:
- Critically ill patients with clinical indications for emergent central venous access.
- Overlying skin infection
- External jugular vein easily visible for cannulation
- Patient in law enforcement custody
- Patient who is known to be pregnant or self identifies as pregnant
- Patient lacking decision making capacity
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: US guided IJ
A physician placed ultrasound-guided IV in the internal jugular vein
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IV catheter placement
다른 이름들:
Ultrasound-guided Internal Jugular vein
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Successful Cannulation of the Internal Jugular Vein
기간: Less than 20 minutes
|
The primary study endpoint is successful cannulation vs failure to cannulate the internal jugular vein.
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Less than 20 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Prevalence of Complications Related to Cannulation of the Internal Jugular Vein.
기간: 24 hours
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Percentage of Participants with successfully placed lines with a complication
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24 hours
|
|
The Median Time Required for Cannulation of the Internal Jugular Vein by an Emergency Physician.
기간: Less than 20 minutes
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The median time it took an Emergency Physician from needle puncture to cannulation in minutes
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Less than 20 minutes
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공동 작업자 및 조사자
수사관
- 수석 연구원: Joseph A Zitek, MD, UMCSN
간행물 및 유용한 링크
일반 간행물
- Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8.
- Teismann NA, Knight RS, Rehrer M, Shah S, Nagdev A, Stone M. The ultrasound-guided "peripheral IJ": internal jugular vein catheterization using a standard intravenous catheter. J Emerg Med. 2013 Jan;44(1):150-4. doi: 10.1016/j.jemermed.2012.02.044. Epub 2012 May 11.
- Stein J, George B, River G, Hebig A, McDermott D. Ultrasonographically guided peripheral intravenous cannulation in emergency department patients with difficult intravenous access: a randomized trial. Ann Emerg Med. 2009 Jul;54(1):33-40. doi: 10.1016/j.annemergmed.2008.07.048. Epub 2008 Sep 27.
- Kornbau C, Lee KC, Hughes GD, Firstenberg MS. Central line complications. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):170-8. doi: 10.4103/2229-5151.164940.
- Butterfield M, Abdelghani R, Mohamad M, Limsuwat C, Kheir F. Using Ultrasound-Guided Peripheral Catheterization of the Internal Jugular Vein in Patients With Difficult Peripheral Access. Am J Ther. 2017 Nov/Dec;24(6):e667-e669. doi: 10.1097/MJT.0000000000000357.
- Kiefer D, Keller SM, Weekes A. Prospective evaluation of ultrasound-guided short catheter placement in internal jugular veins of difficult venous access patients. Am J Emerg Med. 2016 Mar;34(3):578-81. doi: 10.1016/j.ajem.2015.11.069. Epub 2015 Dec 4.
- Zwank MD. Ultrasound-guided catheter-over-needle internal jugular vein catheterization. Am J Emerg Med. 2012 Feb;30(2):372-3. doi: 10.1016/j.ajem.2011.08.013. Epub 2011 Oct 26. No abstract available.
- Ash AJ, Raio C. Seldinger Technique for Placement of "Peripheral" Internal Jugular Line: Novel Approach for Emergent Vascular Access. West J Emerg Med. 2016 Jan;17(1):81-3. doi: 10.5811/westjem.2015.11.28726. Epub 2016 Jan 12.
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
- 16.08.002
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. .
IV 액세스에 대한 임상 시험
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Peter SzmukLuminex Corporation; Outcomes Research Consortium완전한
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Kilis 7 Aralik UniversityMersin University초대로 등록
US guided IJ에 대한 임상 시험
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North American Institute for Continuing Medical...완전한
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Vanderbilt University Medical Center완전한
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Xijing Hospital초대로 등록
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Clinica Universidad de Navarra, Universidad de...아직 모집하지 않음전립선암(전립선 절제술 후)