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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional d'Orléans

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.)

Trial design

Treatments tested in this trial

  • Arterial blood gas
  • Simulated hypotension
  • Arterial Puncture using Blood'Up device

Treatment groups

32 Participants
are divided into 2 treatment groups