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).
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.
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- 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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
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:
- To evaluate the relationship between preoperative frailty status and handgrip strength, and the ultrasonographic anatomical characteristics of the internal jugular vein.
- To investigate the independent predictive role of ultrasonographically measured anatomical parameters of the internal jugular vein in the development of difficult catheterization.
- Conditions
- Frailty, Cardiac Surgery, Central Venous Catheter
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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)
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
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
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
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
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
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
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
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.
- First posted14 Jul 2026
- Study start25 Jul 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatıma Beyza Artıran, Ankara City Hospital Bilkent
- Investigators
- Zeliha Aslı Demir, MD, Principal investigator, Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation
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 25982160Pienta 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 41223914Afilalo 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 24291279Gaber 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