An observational study in Frailty, Cardiac Surgery and Central Venous Catheter, sponsored by Ankara City Hospital Bilkent. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Ankara City Hospital Bilkent · Observational
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.
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:
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 280 is above the median of 225 across 493 observational studies indexed under Frailty.
Browse Frailty studies →Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.
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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.
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Exclusion Criteria
Conditions Affecting Neck Anatomy
Clinical Conditions Affecting Catheterization
Conditions Affecting Frailty and Handgrip Strength Assessment
Conditions Affecting Study Participation
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: At completion of the catheterization procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After anesthesia induction, before catheterization
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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