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Internal Jugular Vein Collapsibility Index for Predicting Post-Induction Hypotension (IJV-CI)

31 de julio de 2026 actualizado por: Elzem SEN, University of Gaziantep

The Value of Internal Jugular Vein Collapsibility Index in Predicting Hypotension Following General Anesthesia Induction in Patients Undergoing Elective Laparoscopic Cholecystectomy

This study aims to investigate whether the Internal Jugular Vein Collapsibility Index (IJV-CI), measured via ultrasonography, can predict hypotension (low blood pressure) that occurs after the induction of general anesthesia. Researchers will measure the diameter of the internal jugular vein in patients before surgery and compare these measurements with the blood pressure changes during the first minutes of anesthesia. The goal is to determine if IJV-CI can be used as a reliable, non-invasive tool to identify patients at higher risk of developing anesthesia-induced hypotension.

Descripción general del estudio

Descripción detallada

Patients aged 18-65 scheduled for elective laparoscopic cholecystectomy under general anesthesia will be included in the study. Exclusion criteria are as follows: Obesity (BMI > 35 kg/m²), presence of Atrial Fibrillation or serious cardiac arrhythmia, history of neck surgery or any pathology preventing internal jugular vein measurement, advanced heart failure (Ejection Fraction < 40%), severe valvular disease, peripheral vascular disease, emergency surgery, and refusal to participate in the study.

Upon arrival in the operating room, patients will be placed in a supine position. The Internal Jugular Vein (IJV) diameter will be monitored using a linear ultrasound probe during spontaneous breathing before anesthesia induction. The maximum and minimum diameters of the IJV during the respiratory cycle will be measured. The Internal Jugular Vein Collapsibility Index (IJV-CI) will be calculated using the following formula: [(IJV maximum diameter - IJV minimum diameter) / IJV maximum diameter] x 100.

Standard anesthesia induction will be performed. Non-invasive blood pressure and heart rate will be monitored and recorded at baseline (0 min), and at 1, 2, 3, 5, 7, 9, and 10 minutes following induction. Post-induction hypotension is defined as a decrease in mean arterial pressure (MAP) of more than 20% from the baseline value. The relationship between the pre-induction IJV-CI values and the development of hypotension during these specific time intervals will be statistically analyzed.

Tipo de estudio

De observación

Inscripción (Estimado)

42

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: ELZEM ŞEN, Associate Professor
  • Número de teléfono: +90 (532) 784 21 52
  • Correo electrónico: drelzem@hotmail.com

Copia de seguridad de contactos de estudio

  • Nombre: KÜBRA BAHAR TÜRKMEN, MD
  • Número de teléfono: +90 (534) 061 74 44
  • Correo electrónico: kbrabaharr@gmail.com

Ubicaciones de estudio

      • Gaziantep, Turquía (Türkiye), 27310
        • Gaziantep University Sahinbey Research and Training Hospital
        • Contacto:
          • KÜBRA BAHAR TÜRKMEN, MD
          • Número de teléfono: +90 (534) 061 74 44
          • Correo electrónico: kbrabaharr@gmail.com
        • Contacto:
          • ELZEM ŞEN, Associate Professor
          • Número de teléfono: +90 (532) 784 21 51
          • Correo electrónico: drelzem@hotmail.com
        • Investigador principal:
          • ELZEM ŞEN, Associate Professor
        • Sub-Investigador:
          • KÜBRA BAHAR TÜRKMEN, MD

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

The study population consists of adult patients aged 18-65 who are scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia. Participants will be selected from patients who meet the ASA I-III physical status criteria. The study focuses on evaluating pre-induction internal jugular vein characteristics using routine clinical monitoring data in a perioperative setting.

Descripción

Inclusion Criteria:

  • Patients aged 18-65 years.
  • Patients with ASA (American Society of Anesthesiologists) physical status I, II, or III.
  • Patients scheduled to receive general anesthesia.
  • Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

  • Patients with obesity (Body Mass Index > 35 kg/m²).
  • Patients with Atrial Fibrillation or other serious cardiac arrhythmias.
  • Patients with a history of neck surgery or any pathology preventing Internal Jugular Vein (IJV) measurement.
  • Patients with advanced heart failure (Ejection Fraction < 40%).
  • Patients with severe valvular heart disease.
  • Patients with peripheral vascular disease.
  • Patients undergoing emergency surgery.
  • Patients who are unwilling to participate in the study.

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
Hypotensive Group
Patients who developed post-induction hypotension (MAP decrease >20% or SBP <90 mmHg). Pre-induction Internal Jugular Vein (IJV) ultrasonography was performed for statistical comparison.
Pre-induction Internal Jugular Vein (IJV) measurement will be performed using a linear ultrasound probe (5-12 MHz) while the patient is in the supine position. The IJV will be imaged in the transverse plane at the level of the cricoid cartilage. During spontaneous breathing, the maximum and minimum diameters of the vein will be recorded. The Collapsibility Index (IJV-CI) will be calculated using these measurements. This non-invasive assessment is performed immediately before the induction of general anesthesia to evaluate its predictive value for post-induction hypotension.
Otros nombres:
  • IJV-CI
  • Internal Jugular Vein Collapsibility Index
  • IJV Ultrasonography
Non-hypotensive Group
Patients aged 18-65 scheduled for elective laparoscopic cholecystectomy who remained hemodynamically stable (no MAP decrease >20% or SBP <90 mmHg) after standard anesthesia induction. Pre-induction IJV measurement was performed to evaluate its predictive capacity."
Pre-induction Internal Jugular Vein (IJV) measurement will be performed using a linear ultrasound probe (5-12 MHz) while the patient is in the supine position. The IJV will be imaged in the transverse plane at the level of the cricoid cartilage. During spontaneous breathing, the maximum and minimum diameters of the vein will be recorded. The Collapsibility Index (IJV-CI) will be calculated using these measurements. This non-invasive assessment is performed immediately before the induction of general anesthesia to evaluate its predictive value for post-induction hypotension.
Otros nombres:
  • IJV-CI
  • Internal Jugular Vein Collapsibility Index
  • IJV Ultrasonography

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Internal Jugular Vein Collapsibility Index (IJV-CI)
Periodo de tiempo: Baseline (pre-induction) and every minute up to 10 minutes following induction or until surgical in
Hypotension is defined as a decrease in Mean Arterial Pressure (MAP) of more than 20% from the baseline value. The predictive value of pre-induction IJV-CI for this occurrence will be assessed.Measurements will be recorded at 0, 1, 2, 3, 5, 7, 9, and 10 minutes following induction, but will stop if surgical incision occurs earlier than 10 minutes
Baseline (pre-induction) and every minute up to 10 minutes following induction or until surgical in

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: ELZEM ŞEN, Associate Professor, Gaziantep University, Faculty of Medicine, Department of Anesthesiology and Reanimation

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)

15 de agosto de 2026

Finalización primaria (Estimado)

1 de enero de 2027

Finalización del estudio (Estimado)

1 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

27 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de abril de 2026

Publicado por primera vez (Actual)

4 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de agosto de 2026

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

31 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

Individual participant data will not be shared to protect patient confidentiality and privacy in accordance with local ethical committee guidelines and institutional data protection policies.

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. .

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