Blood'up Device Versus Manual Palpation for Arterial Puncture in Healthy Volunteers: A Pilot Randomized Study Under Normal and Simulated Hypotension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Success rate of radial arterial puncture performed with and without the Blood'Up device in healthy volunteers with no cardiovascular history
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arterial puncture using manual palpation
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.
干预措施: Arterial blood gas (Other)
Arterial puncture using manual palpation
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.
干预措施: Simulated hypotension (Other)
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.
干预措施: Arterial blood gas (Other)
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.
干预措施: Simulated hypotension (Other)
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.
干预措施: Arterial Puncture using Blood'Up device (Device)
结局指标
主要结局
Success rate of radial arterial puncture performed with and without the Blood'Up device in healthy volunteers with no cardiovascular history
时间窗: 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.
次要结局
- 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)