Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- First Pass Success When Attempting Arterial Catheterization.
研究概览
简要总结
Arterial catheterization is frequently performed on critically ill patients for invasive blood pressure monitoring and/or frequent blood draws, especially arterial blood gas analysis. The distal part of the radial artery (wrist) is the preferred access site.
The potential complications of the procedure are mostly minor and comprise temporary occlusion of the radial artery (RA), hematoma, local infection or bleeding from the puncture site. Major complications including vessel aneurysm or occlusion with threat to hand viability are rare.
The standard approach to catheterization is "blind" puncture of the RA while locating its pulse by palpation, followed by threading a 20 Gauge (20G) angio-catheter into the vessel. Alternatively ultrasound can be used to locate the vessel and guide needle insertion.
To our knowledge, four prospective randomized trials (PRT)5-8 comparing palpation with ultrasound-guided RA catheterization have been conducted so far and one meta-analysis looked at the pooled data obtained from these. The results showed that ultrasound guidance increased the first-attempt success rate at RA catheterization by 71% compared to palpation. The use of ultrasound also significantly reduced the time to successful catheterization, the number of punctures as well as the amount of catheters required per procedure.
None of the prior randomized trials has been conducted in an ICU setting and in three out of the four studies the arterial lines were placed in patients undergoing elective surgery. The investigators hypothesized that ultrasound could improve first attempt success rate while placing arterial catheters in an ICU setting. Ultrasound may also reduce total time to successful insertion and reduce complications.
The investigators plan to randomize patients to either a palpation technique or ultrasound guided catheter insertion and record the above outcomes.
详细描述
The study will be conducted in a prospective randomized design on the patient population of the Surgical Intensive Care Unit (SICU) at Yale New Haven Hospital. All SICU patients in whom the indication for arterial catheterization has been established by the attending physician will be eligible for consented randomization to either the "Palpation" or the "Ultrasound" group.
Once consent from the patient or his/her surrogate has been obtained, eligible patients will be randomized to either the "Palpation" or the "Ultrasound" group. Sequentially numbered sealed envelopes will be maintained in the SICU.
Catheter insertion: The side of insertion (left/right arm) is chosen by the operator. The wrist is positioned by the operator, the skin disinfected and the area draped in a sterile fashion. "Palpation" group": The artery is punctured after location by palpation only. "Ultrasound" group": The artery is punctured under real-time ultrasound only with the probe draped in a sterile sheath. The time from the first skin puncture to confirmed intra-arterial position of the catheter by observing blood return from the catheter is measured with a chronometer by a second person. An arterial pressure waveform must be observed on the monitor to validate intra-arterial catheter placement.
Radial artery cannulation will be performed using the "Radial Artery Catheterization Set with Integral Needle Protection" (Ref. RA-04020-SP, Arrows International Inc., Reading PA 19605, USA) containing a 20G catheter on a 22 gauge (22G) puncture needle and a 0.46 mm spring-wire guide.
For ultrasound-guided catheter insertion, operators will use the "Site-Rite 6 Ultrasound System" with a linear vascular access probe (5-10 MHz) (Bard Access Systems Inc., 605 North 5600 West, Salt Lake City, UT 84116, USA).
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
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All surgical intensive care unit patients at Yale New Haven Hospital in whom the indication for arterial catheterization has been established by the attending physician will be eligible for consented randomization to either the "Palpation" or the "Ultrasound" group.
排除标准
- •The patient or his/her surrogate declines to participate or the patient lacks a radial artery into which a catheter can be place.
结局指标
主要结局
First Pass Success When Attempting Arterial Catheterization.
时间窗: Immediate, upon study entry
first pass success when attempting arterial catheterization of the artery
次要结局
未报告次要终点
