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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07701538
Acronym
FRAILCVC
Enrollment
280
Registered
2026-07-14
Start date
2026-07-25
Completion date
2027-06-01
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Central Venous Catheter, Frailty

Keywords

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

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.

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.

Interventions

PROCEDUREUltrasound-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.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Difficult ultrasound-guided internal jugular vein catheterizationAt completion of the catheterization procedureDifficult 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.

Secondary

MeasureTime frameDescription
Independent predictive value of ultrasonographically measured anatomical parameters for difficult catheterizationUltrasound assessment after anesthesia induction before catheterization; difficult catheterization status at completion of the catheterization procedureThe 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.
Internal jugular vein anteroposterior diameterAfter anesthesia induction, before catheterizationThe anteroposterior diameter of the internal jugular vein will be measured by ultrasound before catheterization. The value will be reported in millimeters.
Internal jugular vein transverse diameterAfter anesthesia induction, before catheterizationThe transverse diameter of the internal jugular vein will be measured by ultrasound before catheterization. The value will be reported in millimeters.
Internal jugular vein cross-sectional areaAfter anesthesia induction, before catheterizationThe cross-sectional area of the internal jugular vein will be measured by ultrasound before catheterization. The value will be reported in square millimeters.
Common carotid artery diameterAfter anesthesia induction, before catheterizationThe diameter of the common carotid artery will be measured by ultrasound before catheterization. The value will be reported in millimeters.
Skin-to-vein distanceAfter anesthesia induction, before catheterizationThe 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.
Internal jugular vein-common carotid artery overlap statusAfter anesthesia induction, before catheterizationThe 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.
Sternocleidomastoid muscle thicknessAfter anesthesia induction, before catheterizationSternocleidomastoid muscle thickness will be measured by ultrasound before catheterization. The value will be reported in millimeters.

Countries

Turkey (Türkiye)

Contacts

CONTACTFatıma Beyza Artıran, MD
beyzaartiran@gmail.com+905073622219
PRINCIPAL_INVESTIGATORZeliha Aslı Demir, MD

Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026