Central Venous Catheter, Critical Ill Patients
Conditions
Keywords
Central venous catheterization, Ultrasound guidance, First-pass failure, Critical care, Internal jugular vein, Prediction
Brief summary
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.
Detailed description
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. A planned cohort of 150 participants will be enrolled. No intervention is assigned by the study protocol, and all catheterization decisions and clinical management will remain at the discretion of the treating clinical team.
Interventions
Ultrasound-internal jugular vein central venous catheterization
Sponsors
Study design
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-Pass Internal Jugular Vein Cannulation Success | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difficult Internal Jugular Vein Catheterization | During the catheterization procedure, approximately 30 minutes | Difficult catheterization defined as a composite outcome of three or more skin punctures, procedure duration longer than 10 minutes, and/or requirement for a change in vascular access site. |
| Total number of skin punctures required to achieve successful catheterization | During the catheterization procedure | Time from initial skin puncture to successful guidewire or catheter placement. |
| Arterial Puncture | During catheterization and immediately after the procedure | Occurrence of inadvertent arterial puncture during the catheterization procedure. |
| Hematoma | During catheterization and immediately after the procedure | Development of a procedure-related hematoma greater than 2 cm. |
| Catheter Malposition | Immediately following catheterization | Catheter tip or catheter position requiring correction or repositioning following insertion. |
| Pneumothorax | Within 24 hours after catheterization | Procedure-related pneumothorax detected following catheterization. Time Frame |
Countries
Turkey (Türkiye)
Contacts
Antalya Health Sciences University
Antalya Health Sciences University