此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Frailty and Ultrasound-Guided Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients (FRAILCVC)

2026年7月8日 更新者:Fatıma Beyza Artıran、Ankara City Hospital Bilkent

Association Between Frailty and Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients: A Prospective Ultrasound-Based Observational Study

This prospective observational study aims to evaluate the association between preoperative frailty and the procedural difficulty of ultrasound-guided internal jugular vein catheterization in adult patients undergoing elective cardiac surgery.

Frailty will be assessed using the Clinical Frailty Scale and handgrip strength measurements. Preprocedural ultrasound evaluation will include internal jugular vein anatomical characteristics such as anteroposterior and transverse vein diameters, cross-sectional area (CSA), common carotid artery diameter, skin-to-vein distance, overlap status, and sternocleidomastoid muscle thickness Catheterization difficulty will be assessed using the Gaber Procedural Difficulty Index.

The study seeks to determine whether frailty and ultrasound-derived anatomical parameters can predict difficult internal jugular venous catheterization and improve preprocedural risk assessment without altering routine clinical care.

研究概览

详细说明

Central venous catheterization via the internal jugular vein is routinely performed in adult cardiac surgery patients for perioperative hemodynamic monitoring and administration of vasoactive medications. Although ultrasound guidance has improved the success and safety of internal jugular vein catheterization, procedural difficulty still varies considerably among patients and may be influenced by patient-related factors beyond vascular anatomy.

Frailty is increasingly recognized as a marker of reduced physiological reserve and adverse perioperative outcomes. However, its relationship with the technical difficulty of ultrasound-guided internal jugular vein catheterization has not been well established. In addition to frailty, reduced muscle strength may reflect diminished physiological reserve and may be associated with anatomical characteristics influencing catheterization difficulty.

This prospective observational study aims to evaluate the association between preoperative frailty and the procedural difficulty of ultrasound-guided internal jugular vein catheterization in adult patients undergoing elective cardiac surgery. The study will also investigate the contribution of handgrip strength and preprocedural ultrasonographic characteristics of the internal jugular vein to catheterization difficulty.

Preoperative frailty will be assessed using the 9-point Clinical Frailty Scale (CFS), ranging from 1 (Very Fit) to 9 (Terminally Ill), with higher scores indicating greater frailty. Handgrip strength will be measured preoperatively using a calibrated hand dynamometer. Three measurements will be obtained from the dominant hand, and the mean value (kg) will be used for analysis. Low muscle strength will be defined according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria as <27 kg for men and <16 kg for women.

Before catheterization, ultrasound evaluation of the internal jugular vein will include anteroposterior and transverse vein diameters, cross-sectional area (CSA), common carotid artery diameter, skin-to-vein distance, overlap status, and sternocleidomastoid muscle thickness. According to the study protocol, CSA will be categorized as <50 mm², 50-100 mm², and >100 mm².

Catheterization difficulty will be assessed using the Gaber Procedural Difficulty Score. The score is based on four procedural domains: number of puncture attempts (1-3 points), cannulation time (1-3 points), procedure-related complications (1-3 points), and procedural success (1-2 points). Higher total scores indicate greater procedural difficulty. Difficult catheterization will be defined as a Gaber Procedural Difficulty Score >4.

The primary aim of this study is to evaluate the relationship between preoperative frailty status and handgrip strength, and the difficulty of ultrasound-guided internal jugular vein catheterization in patients undergoing elective cardiac surgery. Catheterization difficulty will be assessed using the Gaber Procedural Difficulty Index, and difficult catheterization will be defined as a Gaber score >4.

Secondary Objectives:

  1. To evaluate the relationship between preoperative frailty status and handgrip strength, and the ultrasonographic anatomical characteristics of the internal jugular vein.
  2. To investigate the independent predictive role of ultrasonographically measured anatomical parameters of the internal jugular vein in the development of difficult catheterization.

研究类型

观察性的

注册 (估计的)

280

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients (≥18 years) scheduled for elective cardiac surgery at Ankara Bilkent City Hospital who require ultrasound-guided internal jugular vein catheterization as part of routine perioperative care. Participants will undergo preoperative frailty assessment, handgrip strength measurement, and ultrasound evaluation of the internal jugular vein before catheterization.

描述

Inclusion Criteria

  • Adults aged 18 years or older.
  • Scheduled for elective cardiac surgery.
  • Planned ultrasound-guided internal jugular vein catheterization as part of routine perioperative care.
  • Able to undergo preoperative frailty assessment using the Clinical Frailty Scale (CFS).
  • Able to perform handgrip strength measurement.
  • Able to undergo ultrasound assessment of the internal jugular vein.
  • Provided written informed consent.

Exclusion Criteria

Conditions Affecting Neck Anatomy

  1. Previous neck surgery.
  2. History of radiotherapy to the neck region.
  3. Presence of a neck mass, infection, or any lesion that may distort neck anatomy.
  4. Known internal jugular vein thrombosis.
  5. Congenital vascular anomalies causing significant alteration of the internal jugular vein or carotid artery anatomy.

Clinical Conditions Affecting Catheterization

  1. Patients requiring emergency cardiac surgery.
  2. Presence of an existing central venous catheter.
  3. Severe coagulopathy (INR > 2.0 or platelet count < 50,000/mm³).
  4. Hemodynamic instability or requirement for active cardiopulmonary resuscitation.

Conditions Affecting Frailty and Handgrip Strength Assessment

  1. Severe neurological disorders (e.g., advanced dementia or disabling sequelae of stroke).
  2. Orthopedic or neuromuscular disorders affecting upper extremity function.
  3. Inability to perform handgrip strength measurement due to severe arthritis or hand deformity.

Conditions Affecting Study Participation

  1. Cognitive impairment preventing reliable clinical assessment or informed participation.
  2. Refusal to participate in the study.
  3. Any other condition that, in the investigator's judgment, may compromise patient safety or interfere with study participation.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Adult Cardiac Surgery Cohort
Adult patients undergoing elective cardiac surgery who undergo ultrasound-guided internal jugular vein catheterization. Preoperative frailty, handgrip strength, and ultrasound-derived internal jugular venous anatomical parameters are assessed before catheterization.
Ultrasound-guided internal jugular vein catheterization performed as part of routine perioperative clinical care in adult cardiac surgery patients. No additional study-specific intervention is performed.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Difficult ultrasound-guided internal jugular vein catheterization
大体时间:At completion of the catheterization procedure
Difficult catheterization will be defined as a Gaber Procedural Difficulty Score >4. The Gaber Procedural Difficulty Score will be calculated at the completion of the ultrasound-guided internal jugular vein catheterization procedure. The score includes four procedural domains: number of puncture attempts, cannulation time, procedure-related complications, and procedural success. Total scores range from 4 to 11 points, with higher scores indicating greater procedural difficulty.
At completion of the catheterization procedure

次要结果测量

结果测量
措施说明
大体时间
Independent predictive value of ultrasonographically measured anatomical parameters for difficult catheterization
大体时间:Ultrasound assessment after anesthesia induction before catheterization; difficult catheterization status at completion of the catheterization procedure
The independent predictive value of ultrasonographically measured anatomical parameters of the internal jugular vein for difficult catheterization will be evaluated. Anatomical parameters will include internal jugular vein anteroposterior diameter, transverse diameter, cross-sectional area, common carotid artery diameter, skin-to-vein distance, overlap status, and sternocleidomastoid muscle thickness. Difficult catheterization will be defined as a Gaber Procedural Difficulty Score >4. These variables will be evaluated as potential independent predictors of difficult catheterization.
Ultrasound assessment after anesthesia induction before catheterization; difficult catheterization status at completion of the catheterization procedure
Internal jugular vein anteroposterior diameter
大体时间:After anesthesia induction, before catheterization
The anteroposterior diameter of the internal jugular vein will be measured by ultrasound before catheterization. The value will be reported in millimeters.
After anesthesia induction, before catheterization
Internal jugular vein transverse diameter
大体时间:After anesthesia induction, before catheterization
The transverse diameter of the internal jugular vein will be measured by ultrasound before catheterization. The value will be reported in millimeters.
After anesthesia induction, before catheterization
Internal jugular vein cross-sectional area
大体时间:After anesthesia induction, before catheterization
The cross-sectional area of the internal jugular vein will be measured by ultrasound before catheterization. The value will be reported in square millimeters.
After anesthesia induction, before catheterization
Common carotid artery diameter
大体时间:After anesthesia induction, before catheterization
The diameter of the common carotid artery will be measured by ultrasound before catheterization. The value will be reported in millimeters.
After anesthesia induction, before catheterization
Skin-to-vein distance
大体时间:After anesthesia induction, before catheterization
The distance from the skin surface to the anterior wall of the internal jugular vein will be measured by ultrasound before catheterization. The value will be reported in millimeters.
After anesthesia induction, before catheterization
Internal jugular vein-common carotid artery overlap status
大体时间:After anesthesia induction, before catheterization
The anatomical overlap between the internal jugular vein and the common carotid artery will be assessed by ultrasound before catheterization. Overlap status will be reported as a categorical variable.
After anesthesia induction, before catheterization
Sternocleidomastoid muscle thickness
大体时间:After anesthesia induction, before catheterization
Sternocleidomastoid muscle thickness will be measured by ultrasound before catheterization. The value will be reported in millimeters.
After anesthesia induction, before catheterization

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Zeliha Aslı Demir, MD、Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月25日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年7月2日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年7月14日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

This is a single-center academic observational study. Individual participant data (IPD) will not be shared publicly. Only de-identified aggregate study results will be reported in scientific publications.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅