Frailty and Ultrasound-Guided Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients

NCT07701538 | Not Yet Recruiting

• 1 other identifier: FRAILCVC-2026-001
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to evaluate the association between preoperative frailty and the procedural difficulty of ultrasound-guided internal jugular vein catheterization in adult patients undergoing elective cardiac surgery. Frailty will be assessed using the Clinical Frailty Scale and handgrip strength measurements. Preprocedural ultrasound evaluation will include internal jugular vein anatomical characteristics such as anteroposterior and transverse vein diameters, cross-sectional area (CSA), common carotid artery diameter, skin-to-vein distance, overlap status, and sternocleidomastoid muscle thickness Catheterization difficulty will be assessed using the Gaber Procedural Difficulty Index. The study seeks to determine whether frailty and ultrasound-derived anatomical parameters can predict difficult internal jugular venous catheterization and improve preprocedural risk assessment without altering routine clinical care.

Conditions

Frailty; Cardiac Surgery; Central Venous Catheter

Keywords

frailty; central venous catheterization; ultrasound-guided catheterization; cardiac surgery; internal jugular vein; difficult catheterization; handgrip strength; venous anatomy; adult patients

Outcome Measures

Primary Outcomes (1)

• Difficult ultrasound-guided internal jugular vein catheterization

  Difficult catheterization will be defined as a Gaber Procedural Difficulty Score \>4. The Gaber Procedural Difficulty Score will be calculated at the completion of the ultrasound-guided internal jugular vein catheterization procedure. The score includes four procedural domains: number of puncture attempts, cannulation time, procedure-related complications, and procedural success. Total scores range from 4 to 11 points, with higher scores indicating greater procedural difficulty.

  At completion of the catheterization procedure

Secondary Outcomes (8)

• Independent predictive value of ultrasonographically measured anatomical parameters for difficult catheterization

  Ultrasound assessment after anesthesia induction before catheterization; difficult catheterization status at completion of the catheterization procedure

• Internal jugular vein anteroposterior diameter

  After anesthesia induction, before catheterization

• Internal jugular vein transverse diameter

  After anesthesia induction, before catheterization

• Internal jugular vein cross-sectional area

  After anesthesia induction, before catheterization

• Common carotid artery diameter

  After anesthesia induction, before catheterization

Study Arms (1)

Adult Cardiac Surgery Cohort

Adult patients undergoing elective cardiac surgery who undergo ultrasound-guided internal jugular vein catheterization. Preoperative frailty, handgrip strength, and ultrasound-derived internal jugular venous anatomical parameters are assessed before catheterization.

Procedure: Ultrasound-Guided Internal Jugular Vein Catheterization

Interventions

Ultrasound-Guided Internal Jugular Vein Catheterization PROCEDURE

Ultrasound-guided internal jugular vein catheterization performed as part of routine perioperative clinical care in adult cardiac surgery patients. No additional study-specific intervention is performed.

Adult Cardiac Surgery Cohort

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

Adult patients (≥18 years) scheduled for elective cardiac surgery at Ankara Bilkent City Hospital who require ultrasound-guided internal jugular vein catheterization as part of routine perioperative care. Participants will undergo preoperative frailty assessment, handgrip strength measurement, and ultrasound evaluation of the internal jugular vein before catheterization.

You may qualify if:

• Adults aged 18 years or older.
• Scheduled for elective cardiac surgery.
• Planned ultrasound-guided internal jugular vein catheterization as part of routine perioperative care.
• Able to undergo preoperative frailty assessment using the Clinical Frailty Scale (CFS).
• Able to perform handgrip strength measurement.
• Able to undergo ultrasound assessment of the internal jugular vein.
• Provided written informed consent.

You may not qualify if:

• Conditions Affecting Neck Anatomy
• Previous neck surgery.
• History of radiotherapy to the neck region.
• Presence of a neck mass, infection, or any lesion that may distort neck anatomy.
• Known internal jugular vein thrombosis.
• Congenital vascular anomalies causing significant alteration of the internal jugular vein or carotid artery anatomy.
• Clinical Conditions Affecting Catheterization
• Patients requiring emergency cardiac surgery.
• Presence of an existing central venous catheter.
• Severe coagulopathy (INR \> 2.0 or platelet count \< 50,000/mm³).
• Hemodynamic instability or requirement for active cardiopulmonary resuscitation.
• Conditions Affecting Frailty and Handgrip Strength Assessment
• Severe neurological disorders (e.g., advanced dementia or disabling sequelae of stroke).
• Orthopedic or neuromuscular disorders affecting upper extremity function.
• Inability to perform handgrip strength measurement due to severe arthritis or hand deformity.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (4)

• Leong DP, Teo KK, Rangarajan S, Lopez-Jaramillo P, Avezum A Jr, Orlandini A, Seron P, Ahmed SH, Rosengren A, Kelishadi R, Rahman O, Swaminathan S, Iqbal R, Gupta R, Lear SA, Oguz A, Yusoff K, Zatonska K, Chifamba J, Igumbor E, Mohan V, Anjana RM, Gu H, Li W, Yusuf S; Prospective Urban Rural Epidemiology (PURE) Study investigators. Prognostic value of grip strength: findings from the Prospective Urban Rural Epidemiology (PURE) study. Lancet. 2015 Jul 18;386(9990):266-73. doi: 10.1016/S0140-6736(14)62000-6. Epub 2015 May 13.

  PMID: 25982160 BACKGROUND

• Pienta M, He C, Clark MJ, Fanning JS, Azoury FM, Grelecki L, Alnajjar RM, Pruitt AL, Pagani FD; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Clinical Frailty Scale Assessment Before Cardiac Surgery. Ann Thorac Surg. 2026 Mar;121(3):696-703. doi: 10.1016/j.athoracsur.2025.10.028. Epub 2025 Nov 11.

  PMID: 41223914 BACKGROUND

• Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol. 2014 Mar 4;63(8):747-62. doi: 10.1016/j.jacc.2013.09.070. Epub 2013 Nov 27.

  PMID: 24291279 BACKGROUND

• Gaber S, Yehia A, Nabil B, Samir A. Central Venous Catheter Insertion: A Scoring System for Evaluation of Both the Procedure and the Operator (CVCI Score/Gaber Score). Crit Care Res Pract. 2020 Nov 3;2020:8156801. doi: 10.1155/2020/8156801. eCollection 2020.

  PMID: 33204529 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeliha Aslı Demir, MD

  Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatıma Beyza Artıran, MD

CONTACT

+905073622219; beyzaartiran@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 14, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)