Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

8 de julio de 2026 actualizado por: Fatıma Beyza Artıran, Ankara City Hospital Bilkent

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

280

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Fatıma Beyza Artıran, MD
  • Número de teléfono: +905073622219
  • Correo electrónico: beyzaartiran@gmail.com

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difficult ultrasound-guided internal jugular vein catheterization
Periodo de tiempo: At completion of the catheterization procedure
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Independent predictive value of ultrasonographically measured anatomical parameters for difficult catheterization
Periodo de tiempo: Ultrasound assessment after anesthesia induction before catheterization; difficult catheterization status at completion of the catheterization procedure
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
Periodo de tiempo: After anesthesia induction, before catheterization
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
Periodo de tiempo: After anesthesia induction, before catheterization
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
Periodo de tiempo: After anesthesia induction, before catheterization
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
Periodo de tiempo: After anesthesia induction, before catheterization
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
Periodo de tiempo: After anesthesia induction, before catheterization
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
Periodo de tiempo: After anesthesia induction, before catheterization
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
Periodo de tiempo: After anesthesia induction, before catheterization
Sternocleidomastoid muscle thickness will be measured by ultrasound before catheterization. The value will be reported in millimeters.
After anesthesia induction, before catheterization

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Zeliha Aslı Demir, MD, Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

25 de julio de 2026

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

1 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

2 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de julio de 2026

Publicado por primera vez (Actual)

14 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir