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

Association Between Frailty and Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients: A Prospective Ultrasound-Based Observational Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty; Cardiac Surgery; Central Venous Catheter
• Intervention / Treatment: Procedure: Ultrasound-Guided Internal Jugular Vein Catheterization

Detailed Description

Central venous catheterization via the internal jugular vein is routinely performed in adult cardiac surgery patients for perioperative hemodynamic monitoring and administration of vasoactive medications. Although ultrasound guidance has improved the success and safety of internal jugular vein catheterization, procedural difficulty still varies considerably among patients and may be influenced by patient-related factors beyond vascular anatomy.

Frailty is increasingly recognized as a marker of reduced physiological reserve and adverse perioperative outcomes. However, its relationship with the technical difficulty of ultrasound-guided internal jugular vein catheterization has not been well established. In addition to frailty, reduced muscle strength may reflect diminished physiological reserve and may be associated with anatomical characteristics influencing catheterization difficulty.

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. The study will also investigate the contribution of handgrip strength and preprocedural ultrasonographic characteristics of the internal jugular vein to catheterization difficulty.

Preoperative frailty will be assessed using the 9-point Clinical Frailty Scale (CFS), ranging from 1 (Very Fit) to 9 (Terminally Ill), with higher scores indicating greater frailty. Handgrip strength will be measured preoperatively using a calibrated hand dynamometer. Three measurements will be obtained from the dominant hand, and the mean value (kg) will be used for analysis. Low muscle strength will be defined according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria as <27 kg for men and <16 kg for women.

Before catheterization, ultrasound evaluation of the internal jugular vein will include anteroposterior and transverse vein diameters, cross-sectional area (CSA), common carotid artery diameter, skin-to-vein distance, overlap status, and sternocleidomastoid muscle thickness. According to the study protocol, CSA will be categorized as <50 mm², 50-100 mm², and >100 mm².

Catheterization difficulty will be assessed using the Gaber Procedural Difficulty Score. The score is based on four procedural domains: number of puncture attempts (1-3 points), cannulation time (1-3 points), procedure-related complications (1-3 points), and procedural success (1-2 points). Higher total scores indicate greater procedural difficulty. Difficult catheterization will be defined as a Gaber Procedural Difficulty Score >4.

The primary aim of this study is to evaluate the relationship between preoperative frailty status and handgrip strength, and the difficulty of ultrasound-guided internal jugular vein catheterization in patients undergoing elective cardiac surgery. Catheterization difficulty will be assessed using the Gaber Procedural Difficulty Index, and difficult catheterization will be defined as a Gaber score >4.

Secondary Objectives:

1. To evaluate the relationship between preoperative frailty status and handgrip strength, and the ultrasonographic anatomical characteristics of the internal jugular vein.
2. To investigate the independent predictive role of ultrasonographically measured anatomical parameters of the internal jugular vein in the development of difficult catheterization.

• Study Type: Observational
• Enrollment (Estimated): 280

Contacts and Locations

• Study Contact: Name: Fatıma Beyza Artıran, MD; Phone Number: +905073622219; Email: beyzaartiran@gmail.com

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06800
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria

• 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.

Exclusion Criteria

Conditions Affecting Neck Anatomy

1. Previous neck surgery.
2. History of radiotherapy to the neck region.
3. Presence of a neck mass, infection, or any lesion that may distort neck anatomy.
4. Known internal jugular vein thrombosis.
5. Congenital vascular anomalies causing significant alteration of the internal jugular vein or carotid artery anatomy.

Clinical Conditions Affecting Catheterization

1. Patients requiring emergency cardiac surgery.
2. Presence of an existing central venous catheter.
3. Severe coagulopathy (INR > 2.0 or platelet count < 50,000/mm³).
4. Hemodynamic instability or requirement for active cardiopulmonary resuscitation.

Conditions Affecting Frailty and Handgrip Strength Assessment

1. Severe neurological disorders (e.g., advanced dementia or disabling sequelae of stroke).
2. Orthopedic or neuromuscular disorders affecting upper extremity function.
3. Inability to perform handgrip strength measurement due to severe arthritis or hand deformity.

Conditions Affecting Study Participation

1. Cognitive impairment preventing reliable clinical assessment or informed participation.
2. Refusal to participate in the study.
3. Any other condition that, in the investigator's judgment, may compromise patient safety or interfere with study participation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Independent predictive value of ultrasonographically measured anatomical parameters for difficult catheterization	The independent predictive value of ultrasonographically measured anatomical parameters of the internal jugular vein for difficult catheterization will be evaluated. Anatomical parameters will include internal jugular vein anteroposterior diameter, transverse diameter, cross-sectional area, common carotid artery diameter, skin-to-vein distance, overlap status, and sternocleidomastoid muscle thickness. Difficult catheterization will be defined as a Gaber Procedural Difficulty Score >4. These variables will be evaluated as potential independent predictors of difficult catheterization.	Ultrasound assessment after anesthesia induction before catheterization; difficult catheterization status at completion of the catheterization procedure
Internal jugular vein anteroposterior diameter	The anteroposterior diameter of the internal jugular vein will be measured by ultrasound before catheterization. The value will be reported in millimeters.	After anesthesia induction, before catheterization
Internal jugular vein transverse diameter	The transverse diameter of the internal jugular vein will be measured by ultrasound before catheterization. The value will be reported in millimeters.	After anesthesia induction, before catheterization
Internal jugular vein cross-sectional area	The cross-sectional area of the internal jugular vein will be measured by ultrasound before catheterization. The value will be reported in square millimeters.	After anesthesia induction, before catheterization
Common carotid artery diameter	The diameter of the common carotid artery will be measured by ultrasound before catheterization. The value will be reported in millimeters.	After anesthesia induction, before catheterization
Skin-to-vein distance	The distance from the skin surface to the anterior wall of the internal jugular vein will be measured by ultrasound before catheterization. The value will be reported in millimeters.	After anesthesia induction, before catheterization
Internal jugular vein-common carotid artery overlap status	The anatomical overlap between the internal jugular vein and the common carotid artery will be assessed by ultrasound before catheterization. Overlap status will be reported as a categorical variable.	After anesthesia induction, before catheterization
Sternocleidomastoid muscle thickness	Sternocleidomastoid muscle thickness will be measured by ultrasound before catheterization. The value will be reported in millimeters.	After anesthesia induction, before catheterization

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Zeliha Aslı Demir, MD, Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 25, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: cardiac surgery; frailty; internal jugular vein; adult patients; central venous catheterization; handgrip strength; ultrasound-guided catheterization; difficult catheterization; venous anatomy
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty
• Other Study ID Numbers: FRAILCVC-2026-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a single-center academic observational study. Individual participant data (IPD) will not be shared publicly. Only de-identified aggregate study results will be reported in scientific publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No