Association Between Frailty and Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients: A Prospective Ultrasound-Based Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Difficult ultrasound-guided internal jugular vein catheterization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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.
排除标准
- •Conditions Affecting Neck Anatomy
- •Previous neck surgery.
- •History of radiotherapy to the neck region.
- •Presence of a neck mass, infection, or any lesion that may distort neck anatomy.
- •Known internal jugular vein thrombosis.
- •Congenital vascular anomalies causing significant alteration of the internal jugular vein or carotid artery anatomy.
- •Clinical Conditions Affecting Catheterization
- •Patients requiring emergency cardiac surgery.
- •Presence of an existing central venous catheter.
- •Severe coagulopathy (INR > 2.0 or platelet count < 50,000/mm³).
- •Hemodynamic instability or requirement for active cardiopulmonary resuscitation.
- •Conditions Affecting Frailty and Handgrip Strength Assessment
- •Severe neurological disorders (e.g., advanced dementia or disabling sequelae of stroke).
- •Orthopedic or neuromuscular disorders affecting upper extremity function.
- •Inability to perform handgrip strength measurement due to severe arthritis or hand deformity.
- •Conditions Affecting Study Participation
- •Cognitive impairment preventing reliable clinical assessment or informed participation.
- •Refusal to participate in the study.
- •Any other condition that, in the investigator's judgment, may compromise patient safety or interfere with study participation.
研究组 & 干预措施
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.
干预措施: Ultrasound-Guided Internal Jugular Vein Catheterization (Procedure)
结局指标
主要结局
Difficult ultrasound-guided internal jugular vein catheterization
时间窗: 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.
次要结局
- Independent predictive value of ultrasonographically measured anatomical parameters for difficult catheterization(Ultrasound assessment after anesthesia induction before catheterization; difficult catheterization status at completion of the catheterization procedure)
- Internal jugular vein anteroposterior diameter(After anesthesia induction, before catheterization)
- Internal jugular vein transverse diameter(After anesthesia induction, before catheterization)
- Internal jugular vein cross-sectional area(After anesthesia induction, before catheterization)
- Common carotid artery diameter(After anesthesia induction, before catheterization)
- Skin-to-vein distance(After anesthesia induction, before catheterization)
- Internal jugular vein-common carotid artery overlap status(After anesthesia induction, before catheterization)
- Sternocleidomastoid muscle thickness(After anesthesia induction, before catheterization)
研究者
Fatıma Beyza Artıran
Resident Physician, Department of Anesthesiology and Reanimation
Ankara City Hospital Bilkent