Ultrasound-guided Subclavian Venous Catheterization. A Randomized, Single-blind, Controlled Superiority Trial Comparing Standard Ultrasound Guidance and a New Needle-steering Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Successful catheter insertion at first skin puncture: Experimental group
研究概览
简要总结
Up to two-thirds of intensive care unit patients require central venous catheterization for which ultrasound-guided placement is now recommended. In this context, the team performed a prospective randomized simulation trial on a mannequin ("reduced torso model"), to compare the standard ultrasound guidance technique with an ultrasound-guided technique assisted by a new needle-steering device. The preliminary results show a statistically significant improvement in subclavian venipuncture (shorter success time, fewer multiple skin punctures, fewer punctures of the posterior wall of the subclavian vein and needle redirection, greater comfort) and argue for a clinical trial to test the performance of this new device in situation with intensive care unit patients.
The hypothesis is that the needle-steering device will result in a better success rate of subclavian venous cannulation, at first puncture, compared with the conventional ultrasound-guided technique.
详细描述
Central venous catheterization is required in up to two-thirds of intensive care unit patients. Ultrasound-guided placement is now recommended over the "blind" technique to decrease the risk of mechanical complications and duration of the procedure. Although the subclavian site is recommended as first-line because of a lower risk of catheter-related infection and thrombosis (than with internal jugular and femoral sites), this approach is underused (< 20% of regular users). There is also a very low use of ultrasound guidance for subclavian catheterization (< 30% of cases), due to technical difficulties such as more complex visualization of the needle.
New magnetic devices theoretically allow better visualization of the needle, a higher success rate and a lower complication rate. In this context, the team performed a prospective randomized simulation trial on a phantom ("reduced torso model"), comparing the standard ultrasound guidance technique with an ultrasound-guided technique assisted by a new needle-steering device in subclavian central venous catheterization (study in progress). The results of this study show a statistically significant improvement in subclavian venipuncture (shorter success time, fewer multiple skin punctures, fewer punctures of the posterior wall of the subclavian vein and needle redirection, greater comfort).
These preliminary results argue for a clinical trial of the practical performance of this new device in intensive care unit patients.
The hypothesis is that the needle-steering device will result in a higher success rate of subclavian venous cannulation at first puncture compared with the conventional ultrasound guidance technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The patient will be blinded to his or her assignment group. The primary endpoint and secondary endpoints A, D, G, H, will be collected by an assessor independent from the operator, during the central venous catheterization procedure. This assessor will not be blinded to the technique used.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any resuscitation patient requiring subclavian venous catheterization.
- •Patients or representatives must have given free, informed consent and signed the consent form or patient included in an emergency situation
- •Patients must be affiliated to/or beneficiary of a health insurance scheme.
- •All patients must be adults (≥18 years of age).
排除标准
- •Moribund patients
- •Patients with severe primary or secondary hemostasis disorders (Pq < 50 G/L or TP < 30%, or INR > 2).
- •Patients with a PaO2/FiO2 ratio < 100 mmHg in mechanically ventilated patients (invasive or non-invasive ventilation).
- •Patients with a precarious or unstable respiratory status and significant risk of barotrauma
- •Patients for whom it is difficult to visualize the subclavian veins bilaterally (left and right) during ultrasound pre-screening
- •Patients with a malformation/deformity of the subclavian region (congenital or acquired: history of surgery/cervical trauma)
- •Body mass index < 15 kg/m² ou > 40 kg/m²
- •Local infection at the puncture site
- •Thrombosis of the subclavian or axillary vein
- •Patients participating in a category 1 defined RIPH involving subclavian central venous line placement.
- •Patients under court protection, guardianship or curatorship.
- •Pregnant, parturient or breastfeeding women.
研究组 & 干预措施
Standard ultrasound guidance for subclavian venipuncture
62 patients undergoing the usual standard ultrasound guidance technique for subclavian venipuncture
Subclavian venipuncture using the needle-steering device
62 patients undergoing subclavian venipuncture using the needle-steering device
干预措施: Subclavian venipuncture for catheter placement using the needle-steering device (Device)
结局指标
主要结局
Successful catheter insertion at first skin puncture: Experimental group
时间窗: Day 0
The main objective is to compare the success rate of subclavian venous cannulation at first puncture between the conventional ultrasound guidance technique and ultrasound guidance assisted by a needle-steering device. Successful subclavian venous cannulation (success is defined as catheter insertion at first skin puncture). YES/NO
Successful catheter insertion at first skin puncture: Control group
时间窗: Day 0
The main objective is to compare the success rate of subclavian venous cannulation at first puncture between the conventional ultrasound guidance technique and ultrasound guidance assisted by a needle-steering device. Successful subclavian venous cannulation (success is defined as catheter insertion at first skin puncture). YES/NO
次要结局
- E. Hematoma or hemorrhage Grade 3 or over within 24 hours of venous puncture: Experimental group(Hour 24)
- A. Number of skin punctures required before successful central venous catheterism: Control group(Day 0)
- B. Complication rate. All causes, composite score: Experimental group(Hour 24)
- C. Pneumothorax within 24 hours of venous puncture: Control group(Hour 24)
- C bis. Drainage required for pneumothorax within 24 hours of venous puncture: Experimental group(Hour 24)
- D. Arterial puncture within 24 hours of venous puncture: Control group(Day 0)
- G. Time taken from first skin puncture to successful catheter insertion: Experimental group(Day 0)
- H. Failure rate: Experimental group(Day 0)
- A. Number of skin punctures required before successful central venous catheterism: Experimental group(Day 0)
- C. Pneumothorax within 24 hours of venous puncture: Experimental group(Hour 24)
- G. Time taken from first skin puncture to successful catheter insertion: Control group(Day 0)
- C bis. Drainage required for pneumothorax within 24 hours of venous puncture: Control group(Hour 24)
- D. Arterial puncture within 24 hours of venous puncture: Experimental group(Day 0)
- E. Hematoma or hemorrhage Grade 3 or over within 24 hours of venous puncture: Control group(Hour 24)
- B. Complication rate. All causes, composite score: Control group(Hour 24)
- F. Malpositioned catheter seen on the X-ray within 1 hour of venous puncture: Control group(Hour 24)
- H. Failure rate: Control group(Day 0)
- F. Malpositioned catheter seen on the X-ray within 1 hour of venous puncture: Experimental group(Hour 24)
- B. Complication rate. All causes, composite score: Control group(Day 0)
- B. Complication rate. All causes, composite score: Experimental group(Day 0)