Arterial Puncture, Radial Artery Injury, Hypotension, Healthy
Conditions
Keywords
Arterial Puncture, Blood'Up device, hypotension, healthy volunteers, blood gas analysis
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.
Interventions
OTHERArterial blood gas
Each healthy volunteer will undergo arterial blood gas sampling on both wrists using each randomized technique (manual palpation versus the Blood'Up device).
OTHERSimulated hypotension
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).
DEVICEArterial Puncture using Blood'Up device
Blood'Up will be used to detect the radial artery beneath the skin.
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of radial arterial puncture performed with and without the Blood'Up device in healthy volunteers with no cardiovascular history | 5 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Pain with and without the Blood'Up device | 30 minutes | 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). |
| Number of needle redirections with and without the Blood'Up device. | 30 minutes | 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. |
| Immediate complications with and without the Blood'Up device. | 30 minutes | 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). |
Countries
France
Contacts
CONTACTMai-Anh NAY, MD
Outcome results
None listed