Blood'up Device Versus Manual Palpation for Arterial Puncture in Healthy Volunteers: A Pilot Randomized Study Under Normal and Simulated Hypotension

NCT07765199 | Not Yet Recruiting

• 1 other identifier: CHUO-2025-04
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arterial Puncture; Radial Artery Injury; Hypotension; Healthy

Keywords

Arterial Puncture; Blood'Up device; hypotension; healthy volunteers; blood gas analysis

Outcome Measures

Primary Outcomes (1)

• Success rate of radial arterial puncture performed with and without the Blood'Up device in healthy volunteers with no cardiovascular history

  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

Secondary Outcomes (4)

• 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.

  30 minutes

• Pain with and without the Blood'Up device

  30 minutes

• Number of needle redirections with and without the Blood'Up device.

  30 minutes

• Immediate complications with and without the Blood'Up device.

  30 minutes

Study Arms (2)

Arterial puncture using manual palpation

ACTIVE COMPARATOR

The traditional method for performing radial arterial puncture by manual palpation is as follows: * Identification of the radial artery pulsation by palpation by the nurse * Puncture performed at the location where the pulse amplitude is perceived as strongest.

Other: Arterial blood gas; Other: Simulated hypotension

Arterial puncture using Blood'Up device

EXPERIMENTAL

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.

Other: Arterial blood gas; Other: Simulated hypotension; Device: Arterial Puncture using Blood'Up device

Interventions

Arterial blood gas OTHER

Each healthy volunteer will undergo arterial blood gas sampling on both wrists using each randomized technique (manual palpation versus the Blood'Up device).

Arterial puncture using Blood'Up device; Arterial puncture using manual palpation

Simulated hypotension OTHER

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).

Arterial puncture using Blood'Up device; Arterial puncture using manual palpation

Arterial Puncture using Blood'Up device DEVICE

Blood'Up will be used to detect the radial artery beneath the skin.

Arterial puncture using Blood'Up device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHU Orléans

Orléans, 45067, France

Location

Related Publications (5)

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  PMID: 28053756 BACKGROUND

• 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.

  PMID: 28697708 BACKGROUND

• 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.

  PMID: 26206167 BACKGROUND

• 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.

  PMID: 31730754 BACKGROUND

• 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.

  PMID: 3945674 BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Central Study Contacts

Mai-Anh NAY, MD

CONTACT

0238575253; maianh.nay@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A first phase under physiological conditions (normal blood pressure): an arterial puncture will be performed using the Blood'Up device on one radial artery, and without the device on the contralateral radial artery of the same volunteer. A second phase under simulated hypotensive conditions: an arterial puncture will be performed using the Blood'Up device on one radial artery, and without the device on the contralateral radial artery of the same volunteer. Each healthy volunteer will participate in only one of the two conditions, with a maximum of two punctures in total. Each cohort will include 16 volunteers. The study will be randomized according to two criteria: * The order of the tested conditions: manual palpation versus Blood'Up * The side of puncture: left versus right radial artery

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)