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临床试验/NCT07400627
NCT07400627尚未招募不适用

Comparison of the Effectiveness of Ultrasound-Guided Direct and Seldinger Cannulation Techniques in Patients With Anticipated Difficult Radial Artery Cannulation Undergoing Cardiac Surgery

Diskapi Teaching and Research Hospital1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
242
试验地点
1
主要终点
First-Attempt Cannulation Success Rate

研究概览

简要总结

Radial artery cannulation is a routine procedure for invasive hemodynamic monitoring for patients undergoing cardiovascular surgery patients.

Although ultrasound (USG) guidance is known to improve success rates, there is limited data comparing the efficacy of the 'Direct' versus 'Seldinger' techniques specifically in patients with anticipated difficult radial access.

This study aims to compare the effectiveness of USG-guided Direct cannulation and USG-guided Seldinger techniques in adult patients with anticipated difficult radial arterial cannulation.

详细描述

Study Protocol and Patient Assessment: Data collection and the procedural intervention will be performed in the preoperative period, prior to the induction of anesthesia. All patients will undergo a modified Allen test. The radial artery site will be selected based on the following hierarchy: preferably the non-dominant hand (unless surgical plan dictates otherwise), an arm with no history of coronary angiography, and the side determined to be easiest for cannulation via ultrasound (USG) assessment.

Ultrasound Assessment and Exclusion: A 12 MHz linear ultrasound probe will be used for all assessments and procedures. Before the intervention, a detailed sonographic evaluation of the radial artery will be recorded, including:

  • Artery diameter and wall thickness
  • Lumen continuity and flow velocity
  • Presence of calcification, vessel irregularity, or tortuosity
  • Stenosis (percentage) and plaque characterization (stable/unstable; fibrous/fatty)
  • Presence of hematoma, posterior wall injury, or dissection
  • Skin- mid radial artery distance Patients with significant stenosis where an appropriate arterial segment matching the cannula diameter and length cannot be identified will be excluded from the study, and cannulation will be performed at an alternative site.

Randomization and Positioning: Patients will be randomized into two groups using a computer-generated random number table:

  • Group D (Direct): Cannulation performed using the catheter-over-needle technique.
  • Group S (Seldinger): Cannulation performed using the catheter-over-guide-wire 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
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

入选标准

  • Patients aged 18 years or older
  • American Society of Anesthesiologists (ASA) physical status I-IV
  • Patients scheduled for cardiovascular surgery requiring invasive arterial monitoring

排除标准

  • Patients undergoing emergency surgery
  • Coagulation disorders or known coagulopathy
  • Presence of an arteriovenous fistula
  • Patients in shock or hemodynamically instable
  • Patients requiring mechanical circulatory support
  • History of Raynaud's phenomenon
  • Refusal to participate in the study

研究组 & 干预措施

Ultrasound-Guided Direct Cannulation Technique

Experimental

Patients in this group will undergo radial artery cannulation using the ultrasound-guided direct technique.

干预措施: Ultrasound-Guided Direct Cannulation Technique (Procedure)

Ultrasound-Guided Seldinger Cannulation Technique

Active Comparator

Patients in this group will undergo radial artery cannulation using the ultrasound-guided Seldinger technique.

干预措施: Ultrasound-Guided Seldinger Cannulation Technique (Procedure)

结局指标

主要结局

First-Attempt Cannulation Success Rate

时间窗: 10 min before anesthesia induction

The proportion of patients in whom radial artery cannulation is successfully performed (verified by the appearance of the arterial pressure waveform on the monitor) with a single skin puncture

次要结局

  • Number of Cannulation Attempts(10 min before anesthesia induction)
  • Radial artery cannulation time(10 min before anesthesia induction)
  • Incidence of Procedure-Related Complications(Postoperative 24th hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

DILEK YAZICIOGLU

Professor of Anesthesiology

Diskapi Teaching and Research Hospital

研究点 (1)

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