Blood'up Device Versus Manual Palpation for Arterial Puncture in Healthy Volunteers: A Pilot Randomized Study Under Normal and Simulated Hypotension
Arterial puncture is a common procedure in the management of hospitalized patients. It is most often performed at the level of the radial artery and allows arterial blood gas analysis.
The success rate of arterial puncture varies widely in the literature. This procedure is moderately painful and may cause significant discomfort, particularly in cases of repeated attempts. First-attempt success is therefore important to reduce both pain and the risk of local complications associated with multiple punctures.
In routine practice, arterial puncture is performed using manual palpation of the radial artery, typically by a trained nurse. In case of failure, a physician may attempt the procedure, often using ultrasound guidance. However, ultrasound is not routinely used and requires specific training and organizational protocols for nurse use.
In hypotensive conditions, such as shock, the radial pulse may become difficult to palpate, making arterial puncture more challenging when using conventional techniques.
The Blood'up device (Arterya, Hérouville, France) is a non-invasive device currently under development that assists in arterial localization. It is applied to the wrist and projects a light signal indicating the position of the artery. This localization is based on ultrasound technology using piezoelectric sensors integrated into the device.
The aim of this study is to evaluate the effectiveness of the Blood'up device for radial artery localization in healthy volunteers, both under physiological conditions (normal blood pressure) and under simulated hypotensive conditions.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mai-Anh NAY, MD
- 전화번호: 0238575253
- 이메일: maianh.nay@chu-orleans.fr
연구 장소
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Orléans, 프랑스, 45067
- Chu Orleans
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연락하다:
- Mai-Anh NAY, MD
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수석 연구원:
- May Anh NAY, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Participant who has agreed to take part in the study
- No history of cardiovascular disease and a positive Allen test (the Allen test confirms the presence of collateral circulation between the radial and ulnar arteries)
- Age ≥ 18 years
- Body mass index (BMI) < 30 kg/m²
Exclusion Criteria:
- Raynaud's syndrome/disease
- Damaged or injured skin at the puncture site or at the Blood'Up device contact area
- Upper limb amputation
- Contraindication to arterial puncture in one or both upper limbs (e.g., skin lesion, lymph node dissection, etc.)
- Contraindication to extrinsic arterial compression
- Therapeutic anticoagulation
- Known allergy to thermoplastic (ABS)
- Known allergy to EMLA patch (lidocaine or prilocaine)
- Pregnant or breastfeeding women
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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활성 비교기: Arterial puncture using manual palpation
The traditional method for performing radial arterial puncture by manual palpation is as follows:
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Each healthy volunteer will undergo arterial blood gas sampling on both wrists using each randomized technique (manual palpation versus the Blood'Up device).
Only for the second cohort with simulated hypotension, which will include 16 healthy volunteers: Hypotension will be simulated by extrinsic compression using a blood pressure cuff adapted to the volunteer's arm circumference. The (manual) blood pressure cuff will be inflated and maintained to achieve a mean arterial pressure of 60 mmHg (with hypotension defined as a mean arterial pressure below 65 mmHg). Blood pressure will be measured using a non-invasive hemodynamic monitoring device (ClearSight®, Edwards Lifesciences, Mississauga, Canada). |
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실험적: Arterial puncture using Blood'Up device
Blood'Up is a portable, reusable, non-sterile Class I medical device that uses ultrasound to detect the radial artery beneath the skin.
It projects two puncture points connected by a line onto the skin surface directly above the artery.
Unlike ultrasound-guided or palpation-based techniques, the device allows the healthcare professional to keep both hands free, enabling the puncture to be performed under optimal conditions.
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Each healthy volunteer will undergo arterial blood gas sampling on both wrists using each randomized technique (manual palpation versus the Blood'Up device).
Only for the second cohort with simulated hypotension, which will include 16 healthy volunteers: Hypotension will be simulated by extrinsic compression using a blood pressure cuff adapted to the volunteer's arm circumference. The (manual) blood pressure cuff will be inflated and maintained to achieve a mean arterial pressure of 60 mmHg (with hypotension defined as a mean arterial pressure below 65 mmHg). Blood pressure will be measured using a non-invasive hemodynamic monitoring device (ClearSight®, Edwards Lifesciences, Mississauga, Canada).
Blood'Up will be used to detect the radial artery beneath the skin.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Success rate of radial arterial puncture performed with and without the Blood'Up device in healthy volunteers with no cardiovascular history
기간: 5 minutes
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Success is defined as successful puncture of the radial artery with confirmation of the arterial nature of the sample by blood gas analysis. Only one puncture (defined as a single skin puncture) will be performed on each wrist. If the needle is withdrawn without obtaining blood return, this will be considered a failed arterial puncture. Similarly, the absence of blood return within one minute after skin puncture will also be considered a failure. |
5 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Procedure time: from device placement to blood return in the syringe when using the Blood'Up device; and from the start of palpation to blood return in the syringe for manual palpation.
기간: 30 minutes
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Procedure time is defined as the time from the start of device placement to the onset of blood return in the arterial syringe (expected volume: 1 mL). For the Blood'Up device, the start is defined as the moment the device is placed on the volunteer's skin. For manual palpation, the start of palpation defines the start of the procedure. In both cases (Blood'Up and manual palpation), the maximum allowed procedure time is 1 minute. Similarly, the absence of blood return within one minute after skin puncture will be considered a failure. |
30 minutes
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Pain with and without the Blood'Up device
기간: 30 minutes
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Pain will be assessed immediately after each puncture by asking the participant to rate the maximum pain experienced during the procedure using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
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30 minutes
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Number of needle redirections with and without the Blood'Up device.
기간: 30 minutes
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Number of needle redirections during each puncture, defined as any change in needle angulation (self-reported by the nurse performing the procedure).
A puncture is defined as a single skin breach by the needle; as long as the needle is not completely withdrawn from the skin, all manipulations are considered part of the same puncture, regardless of the number of redirections.
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30 minutes
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Immediate complications with and without the Blood'Up device.
기간: 30 minutes
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Complications related to arterial puncture occurring within 5 minutes after the procedure: hematoma at the puncture site, suspected nerve injury (paresthesia), or vasovagal response (pallor, sweating, bradycardia, syncope).
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30 minutes
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Bohannon RW. Test-retest reliability of hand-held dynamometry during a single session of strength assessment. Phys Ther. 1986 Feb;66(2):206-9. doi: 10.1093/ptj/66.2.206.
- Bobos P, Nazari G, Lu Z, MacDermid JC. Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2020 Mar;101(3):553-565. doi: 10.1016/j.apmr.2019.10.183. Epub 2019 Nov 13.
- Bertrand AM, Fournier K, Wick Brasey MG, Kaiser ML, Frischknecht R, Diserens K. Reliability of maximal grip strength measurements and grip strength recovery following a stroke. J Hand Ther. 2015 Oct-Dec;28(4):356-62; quiz 363. doi: 10.1016/j.jht.2015.04.004. Epub 2015 May 9.
- Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed definitions and a shared vision for new standards in stroke recovery research: The Stroke Recovery and Rehabilitation Roundtable taskforce. Int J Stroke. 2017 Jul;12(5):444-450. doi: 10.1177/1747493017711816.
- Barthelemy A, Gagnon DH, Duclos C. Gait-like vibration training improves gait abilities: a case report of a 62-year-old person with a chronic incomplete spinal cord injury. Spinal Cord Ser Cases. 2016 Jul 21;2:16012. doi: 10.1038/scsandc.2016.12. eCollection 2016.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHUO-2025-04
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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