| Registry | NCT07765199 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 32 (Estimated) |
| Sponsor | Centre Hospitalier Régional d'Orléans (Other) |
| Conditions | Arterial Puncture, Radial Artery Injury, Hypotension, Healthy |
| Interventions | Arterial blood gas, Simulated hypotension, Arterial Puncture using Blood'Up device (Other, device) |
| Dates | start 2026-09-01 (estimated), primary completion 2027-09-01 (estimated), completion 2027-09-01 (estimated), first posted 2026-08-14, last updated 2026-08-14 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Arterial Puncture All trials for Radial Artery Injury All trials of Arterial blood gas All trials of 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arterial puncture using manual palpation | Active comparator | Other: Arterial blood gas; Other: Simulated hypotension | 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. |
| Arterial puncture using Blood'Up device | Experimental | Other: Arterial blood gas; Other: Simulated hypotension; Device: 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. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| CHU Orléans | Orléans | France |