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- Ensaio Clínico NCT07565025
Internal Jugular Vein Collapsibility Index for Predicting Post-Induction Hypotension (IJV-CI)
The Value of Internal Jugular Vein Collapsibility Index in Predicting Hypotension Following General Anesthesia Induction in Patients Undergoing Elective Laparoscopic Cholecystectomy
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: ELZEM ŞEN, Associate Professor
- Número de telefone: +90 (532) 784 21 52
- E-mail: drelzem@hotmail.com
Estude backup de contato
- Nome: KÜBRA BAHAR TÜRKMEN, MD
- Número de telefone: +90 (534) 061 74 44
- E-mail: kbrabaharr@gmail.com
Locais de estudo
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Gaziantep, Turquia (Türkiye), 27310
- Gaziantep University Sahinbey Research and Training Hospital
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Contato:
- KÜBRA BAHAR TÜRKMEN, MD
- Número de telefone: +90 (534) 061 74 44
- E-mail: kbrabaharr@gmail.com
-
Contato:
- ELZEM ŞEN, Associate Professor
- Número de telefone: +90 (532) 784 21 51
- E-mail: drelzem@hotmail.com
-
Investigador principal:
- ELZEM ŞEN, Associate Professor
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Subinvestigador:
- KÜBRA BAHAR TÜRKMEN, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
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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.
Outros nomes:
|
|
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Internal Jugular Vein Collapsibility Index (IJV-CI)
Prazo: Baseline (pre-induction) and every minute up to 10 minutes following induction or until surgical in
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: ELZEM ŞEN, Associate Professor, Gaziantep University, Faculty of Medicine, Department of Anesthesiology and Reanimation
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026/217
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Descrição do plano IPD
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