Development and Validation of an Ultrasound-Based Difficult Cannulation Risk Score for Pre-procedural Internal Jugular Vein Catheterization in Critically Ill Patients: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- First-Pass Internal Jugular Vein Cannulation Success
研究概览
简要总结
Ultrasound-guided internal jugular vein (IJV) catheterization is widely used in critically ill patients. Despite ultrasound guidance, difficult catheterization and first-pass failure remain clinically important and may increase the risk of mechanical complications. Pre-procedural characteristics of the IJV, its anatomical relationship with the common carotid artery (CCA), head rotation, and operator experience may influence procedural success.
The ROTATE-ICU study is a prospective observational cohort study designed to investigate pre-procedural ultrasound and clinical predictors of difficult IJV catheterization in critically ill adults. Consecutive adult intensive care unit patients undergoing ultrasound-guided IJV central venous catheterization will undergo standardized pre-procedural ultrasound assessment. IJV anterior-posterior diameter, skin-to-vessel depth, IJV position relative to the CCA, head rotation angle, operator experience, and relevant clinical and procedural characteristics will be recorded.
The primary objective is to develop and internally validate a clinical prediction model for cannulation difficulty and first-pass cannulation outcome. Secondary objectives include evaluating the relationship between head rotation and IJV morphology and describing the association between complete IJV collapse and procedural outcomes. The planned enrollment is 150 participants.
详细描述
Central venous catheterization is a common procedure in critically ill patients. Ultrasound guidance improves procedural safety; however, first-pass failure and difficult catheterization remain common and may lead to repeated punctures, prolonged procedure time, arterial puncture, hematoma, and other mechanical complications.
Anatomical characteristics of the internal jugular vein (IJV), particularly vessel diameter and its positional relationship with the common carotid artery (CCA), may influence cannulation difficulty. Operator experience and head position may also modify procedural success. Nevertheless, these factors have rarely been integrated into a prospective pre-procedural prediction strategy in critically ill patients.
ROTATE-ICU is a prospective, single-center observational cohort study enrolling consecutive adult intensive care unit patients undergoing ultrasound-guided IJV central venous catheterization. Before catheterization, patients will undergo standardized ultrasound examination with measurement of the IJV anterior-posterior diameter and skin-to-vessel depth and classification of the IJV position relative to the CCA. Head rotation angle and operator experience will also be recorded.
Procedural outcomes including first-pass cannulation success, number of skin punctures, procedure duration, need for site change, and mechanical complications will be prospectively documented. Difficult catheterization will be defined using a composite of multiple punctures, prolonged procedure duration, and/or need for access-site change.
The study aims to determine independent pre-procedural predictors of cannulation outcome and to develop a clinically applicable ultrasound-based risk prediction model. Model discrimination and calibration will be assessed and internal validation will be performed.
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
- •Age ≥18 years
- •Admission to the intensive care unit.
- •Clinical indication for central venous catheterization
- •Planned internal jugular vein access
- •Planned ultrasound-guided catheterization
- •Written informed consent obtained from the participant or legally authorized representative, where required
排除标准
- •Active cardiopulmonary resuscitation at the time of catheterization
- •Neck anatomical abnormality preventing standard IJV assessment or catheterization
- •Neck hematoma
- •Active local soft-tissue infection at the proposed access site
- •Planned vascular access through a site other than the internal jugular vein
- •Planned catheterization without ultrasound guidance
- •Refusal or inability to obtain required informed consent
研究组 & 干预措施
Critically Ill Patients Undergoing IJV Catheterization
Adult intensive care unit patients undergoing clinically indicated ultrasound-internal jugular vein central venous catheterization. Participants will undergo standardized pre-procedural ultrasound assessment and prospective recording of procedural outcomes. No study-specific therapeutic intervention will be assigned.
干预措施: IJV Catheterization (Other)
结局指标
主要结局
First-Pass Internal Jugular Vein Cannulation Success
时间窗: During the catheterization procedure, from initial skin puncture until successful guidewire placement, approximately 30 minutes
Successful advancement of the guidewire following the first skin puncture without needle redirection or an additional skin puncture.
次要结局
- Difficult Internal Jugular Vein Catheterization(During the catheterization procedure, approximately 30 minutes)
- Total number of skin punctures required to achieve successful catheterization(During the catheterization procedure)
- Arterial Puncture(During catheterization and immediately after the procedure)
- Hematoma(During catheterization and immediately after the procedure)
- Catheter Malposition(Immediately following catheterization)
- Pneumothorax(Within 24 hours after catheterization)