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

NCT07764562 | Completed

• 1 other identifier: 2026-250
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Ill Patients; Central Venous Catheter

Keywords

Central venous catheterization; Ultrasound guidance; First-pass failure; Critical care; Internal jugular vein; Prediction

Outcome Measures

Primary Outcomes (1)

• First-Pass Internal Jugular Vein Cannulation Success

  Successful advancement of the guidewire following the first skin puncture without needle redirection or an additional skin puncture.

  During the catheterization procedure, from initial skin puncture until successful guidewire placement, approximately 30 minutes

Secondary Outcomes (6)

• 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

Other Outcomes (3)

• Association Between Head Rotation Angle and IJV AP Diameter

  Immediately before catheterization.

• Association Between Head Rotation and IJV-CCA Positional Relationship

  Immediately before catheterization.

• Complete IJV Collapse

  Immediately before and during catheterization.

Study Arms (1)

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.

Other: IJV Catheterization

Interventions

IJV Catheterization OTHER

Ultrasound-internal jugular vein central venous catheterization

Critically Ill Patients Undergoing IJV Catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill adults requiring ultrasound-guided IJV CVC

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antalya Health Sciences University: lead

Study Sites (1)

Antalya training and research hospital health sciences university

Antalya, 07059, Turkey (Türkiye)

Location

Related Publications (1)

• Zawadka M, Czarnik T, Gawda R, Milobedzka M, Trzebicka J, Krolicki T, Owczuk R, Czuczwar M, Bialka S, Gola W, Aszkielowicz A, Latos M, Wludarczyk A, Szczeklik W, Putowski Z. Central venous cannulation in critically ill patients: guidelines of the Polish Society of Anaesthesiology and Intensive Therapy. Anaesthesiol Intensive Ther. 2026 May 21;58(1):84-105. doi: 10.5114/ait/220388.

  PMID: 42246225 BACKGROUND

Study Officials

• Şule Asri̇

  Antalya Health Sciences University

  PRINCIPAL INVESTIGATOR

• Asri, M.D

  Antalya Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: June 25, 2026
• Primary Completion: September 1, 2026
• Study Completion: September 2, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)