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NCT Number: NCT07764562

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antalya training and research hospital health sciences university

Antalya, 07059, Turkey (Türkiye)

Location status: Recruiting

Location contact

Şule Asri̇, M.D

CONTACT

[email protected]

05367868257

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IJV Catheterization

Other

Ultrasound-internal jugular vein central venous catheterization

Primary outcomes

  1. First-Pass Internal Jugular Vein Cannulation Success

    Time frame: 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 outcomes

  1. Difficult Internal Jugular Vein Catheterization

    Time frame: 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.

  2. Total number of skin punctures required to achieve successful catheterization

    Time frame: During the catheterization procedure

    Time from initial skin puncture to successful guidewire or catheter placement.

  3. Arterial Puncture

    Time frame: During catheterization and immediately after the procedure

    Occurrence of inadvertent arterial puncture during the catheterization procedure.

  4. Hematoma

    Time frame: During catheterization and immediately after the procedure

    Development of a procedure-related hematoma greater than 2 cm.

  5. Catheter Malposition

    Time frame: Immediately following catheterization

    Catheter tip or catheter position requiring correction or repositioning following insertion.

  6. Pneumothorax

    Time frame: Within 24 hours after catheterization

    Procedure-related pneumothorax detected following catheterization.

    Time Frame

Other outcomes

  1. Association Between Head Rotation Angle and IJV AP Diameter

    Time frame: Immediately before catheterization.

    Change/difference in pre-procedural IJV anterior-posterior diameter according to operator-selected head rotation angle.

  2. Association Between Head Rotation and IJV-CCA Positional Relationship

    Time frame: Immediately before catheterization.

    Distribution of IJV positional categories relative to the common carotid artery according to head rotation angle.

  3. Complete IJV Collapse

    Time frame: Immediately before and during catheterization.

    Proportion of participants with complete absence of detectable IJV lumen on pre-procedural ultrasound (AP diameter = 0 mm) and associated catheterization outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Dilara Tüfek Öztan, M.D

CONTACT

[email protected]

00905054501062

Şule Asri̇, M.D

CONTACT

[email protected]

00905367868257

Sponsors and collaborators

Lead sponsor

Antalya Health Sciences University

Other

Registry information

Official study title

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

Acronym: ROTATE-ICU

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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