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

2026. július 8. frissítette: 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.

A tanulmány áttekintése

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

280

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
Beavatkozás / kezelés
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Difficult ultrasound-guided internal jugular vein catheterization
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Independent predictive value of ultrasonographically measured anatomical parameters for difficult catheterization
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Nyomozók

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

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. július 25.

Elsődleges befejezés (Becsült)

2027. május 1.

A tanulmány befejezése (Becsült)

2027. június 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. július 2.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 8.

Első közzététel (Tényleges)

2026. július 14.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. július 14.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 8.

Utolsó ellenőrzés

2026. július 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

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.

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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