Clinical Trial

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

Study acronym: ROTATE-ICU
Recruiting
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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.
Trial Details
NCT Number NCT07764562
Lead Sponsor Antalya Health Sciences University
Conditions Adult Critically Ill Patients Who Require Ultrasound-guided Internal Jugular Vein Central Venous Catheterization
Enrollment 150 participants
Start Date 2026-06-26
Primary Completion 2026-09-26 (estimated)
Study Completion 2026-09-26 (estimated)
Updated on ClinicalTrials.gov 2026-08-14