- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04730479
Echography to Predict Radial Artery Catheterization Failure (EPRAC) (EPRAC)
Ultrasound Prediction of Radial Arterial Catheterization Failure in Patients Undergoing Cardiac or Aortic Surgery: a Prospective Study
연구 개요
상태
상세 설명
The Arterial Catheter (KTA) enables continuous measurement of invasive blood pressure in patients with accurate and reliable hemodynamic monitoring. Radial Artery Catheterization is the currently recommended placement site.
In patients undergoing cardiac or aortic surgery, placement of a radial KTA is sometimes difficult, with a failure rate of around 15%. It is also a source of local complications and prolongation of the anesthetic duration.
There is no predictive diagnostic test for failed radial KTA placement in anesthesia.
Accurately predicting the failure of radial catheterization by echography will, in the future, make it possible to offer "at risk" patients an immediate catheterization in an other site as for example brachial site.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
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Montpellier, 프랑스, 34295
- University Hospital of Montpellier
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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:
- Aged from 18 years old
- Be operated for a scheduled cardiac or aortic surgery
- Be able to complete all the visits and follow the study procedures
- Subjects must be covered by public health insurance
Exclusion Criteria:
- Patients protected by law or Absence of signed informed consent
- Emergency Surgery Patient
- Patient already with an arterial catheter
- Patient with Radial Arterial Catheter Contraindication
- Radial arterial catheter placed by an anesthesiologist nurse student
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists
기간: Day 1
|
Failure to insert the radial KTA by the nurse anesthesiologist defined as follows: ≥ 3 punctures (by the nurse anesthetist) or need to change of doctor operator (nurse anesthesiologist to Anesthesiologist - Resuscitator) or change of puncture site (radial to radial contralateral or other site).
All professionals involved are blinded to the echographic measures of the radial artery.
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Day 1
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Internal radial artery diameter
기간: Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
External radial artery diameter
기간: Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
Internal area of the radial artery
기간: Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
External area of the radial artery
기간: Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
Calcification of arterial wall (yes/no)
기간: Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
Thickness of arteria wall
기간: Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
Ratio between internal and external arteria diameter
기간: Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
Clinical characteristics at baseline
기간: Day 1
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Age, sex, body mass index, ASA score, duration of preoperative fasting, cardiovascular risk factors, cardiovascular conditions, wrist circumference, pulse force of the radial, ulnar, and brachial arteries (no pulse / feeble pulse / normal pulse), mean arterial pressure at punction time, dose of vasopressants (ephedrine, neosynephrine, noradrenaline) at punction time
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Day 1
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Punction-related adverse events
기간: 6 months
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Hematoma, dissection, thrombosis, ischemia, false aneuvrysm, infection, pain.
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6 months
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Duration of arterial punction
기간: Day 1
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delay between first pulse palpation and end of bandage on a functional catheter
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Day 1
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Duration of patient management
기간: 28 days
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duration of anaesthesia, duration of presence in surgery room, length of hospital stay
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28 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jérôme PANIEGO, University Hospital of Montpellier, Montpellier, France, 34295
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
- RECHMPL20_0091
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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