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Development and Validation of an Ultrasound-Based Difficult Cannulation Risk Score

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07764562
Acronym
ROTATE-ICU
Enrollment
120
Registered
2026-08-14
Start date
2026-06-25
Completion date
2026-09-02
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Venous Catheter, Critical Ill Patients

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

OTHERIJV Catheterization

Ultrasound-internal jugular vein central venous catheterization

Sponsors

Antalya Health Sciences University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
First-Pass Internal Jugular Vein Cannulation SuccessDuring the catheterization procedure, from initial skin puncture until successful guidewire placement, approximately 30 minutesSuccessful advancement of the guidewire following the first skin puncture without needle redirection or an additional skin puncture.

Secondary

MeasureTime frameDescription
Difficult Internal Jugular Vein CatheterizationDuring the catheterization procedure, approximately 30 minutesDifficult 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 catheterizationDuring the catheterization procedureTime from initial skin puncture to successful guidewire or catheter placement.
Arterial PunctureDuring catheterization and immediately after the procedureOccurrence of inadvertent arterial puncture during the catheterization procedure.
HematomaDuring catheterization and immediately after the procedureDevelopment of a procedure-related hematoma greater than 2 cm.
Catheter MalpositionImmediately following catheterizationCatheter tip or catheter position requiring correction or repositioning following insertion.
PneumothoraxWithin 24 hours after catheterizationProcedure-related pneumothorax detected following catheterization. Time Frame

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORŞule Asri̇

Antalya Health Sciences University

PRINCIPAL_INVESTIGATORAsri, M.D

Antalya Health Sciences University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026