AzTrials
AzTrials

FrailtyFRAILCVCNCT07701538

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

An observational study of Frailty and Cardiac Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Frailty, Cardiac Surgery, Central Venous Catheter
What is being tested?
Ultrasound-Guided Internal Jugular Vein Catheterization
Type of treatment
Surgery or procedure
How many people
280 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Jul 2026to Jun 2027
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.
  • Conditions Affecting Study Participation
  • Cognitive impairment preventing reliable clinical assessment or informed participation.
  • Refusal to participate in the study.
  • Any other condition that, in the investigator's judgment, may compromise patient safety or interfere with study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fatıma Beyza Artıran, MD contact

+905073622219

beyzaartiran@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ankara Bilkent City Hospital

    Ankara, Ankara, 06800

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.
Being tested
Ultrasound-Guided Internal Jugular Vein Catheterization
Keywords
frailty, central venous catheterization, ultrasound-guided catheterization, cardiac surgery, internal jugular vein, difficult catheterization, handgrip strength, venous anatomy, adult patients
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-Guided Internal Jugular Vein CatheterizationProcedure or surgery

    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.

Study groups in NCT07701538
Study groupRoleWhat they receive
Adult Cardiac Surgery CohortAdult 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.
Receives: Procedure: Ultrasound-Guided Internal Jugular Vein Catheterization

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.Gaber Procedural Difficulty Score:

    Minimum score: 4 points Maximum score: 11 points 4 points: Easy, uncomplicated catheterization 5-11 points: Difficult catheterization (Gaber score >4) Higher scores indicate greater procedural difficulty.

    Measured: At completion of the catheterization procedure

Secondary outcomes (8)
  1. 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.

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

  2. 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.

    Measured: After anesthesia induction, before catheterization

  3. 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.

    Measured: After anesthesia induction, before catheterization

  4. 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.

    Measured: After anesthesia induction, before catheterization

  5. 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.

    Measured: After anesthesia induction, before catheterization

  6. 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.

    Measured: After anesthesia induction, before catheterization

  7. 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.

    Measured: After anesthesia induction, before catheterization

  8. Sternocleidomastoid muscle thickness

    Sternocleidomastoid muscle thickness will be measured by ultrasound before catheterization. The value will be reported in millimeters.

    Measured: After anesthesia induction, before catheterization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start25 Jul 2026
  3. Primary completionMay 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07701538
Sponsor's protocol ID
FRAILCVC-2026-001
Acronym
FRAILCVC
Status last verified
Jul 2026
First submitted
2 Jul 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 25982160
  • 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.

    PubMed 41223914
  • 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.

    PubMed 24291279
  • 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.

    PubMed 33204529

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in