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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mai-Anh NAY, MD
- 電話番号：0238575253
- メール：maianh.nay@chu-orleans.fr
研究場所
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Orléans、フランス、45067
- Chu Orleans
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コンタクト：
- Mai-Anh NAY, MD
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主任研究者：
- May Anh NAY, MD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
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研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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