- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: ELZEM ŞEN, Associate Professor
- Numéro de téléphone: +90 (532) 784 21 52
- E-mail: drelzem@hotmail.com
Sauvegarde des contacts de l'étude
- Nom: KÜBRA BAHAR TÜRKMEN, MD
- Numéro de téléphone: +90 (534) 061 74 44
- E-mail: kbrabaharr@gmail.com
Lieux d'étude
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Gaziantep, Turquie (Türkiye), 27310
- Gaziantep University Sahinbey Research and Training Hospital
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Contact:
- KÜBRA BAHAR TÜRKMEN, MD
- Numéro de téléphone: +90 (534) 061 74 44
- E-mail: kbrabaharr@gmail.com
-
Contact:
- ELZEM ŞEN, Associate Professor
- Numéro de téléphone: +90 (532) 784 21 51
- E-mail: drelzem@hotmail.com
-
Chercheur principal:
- ELZEM ŞEN, Associate Professor
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Sous-enquêteur:
- KÜBRA BAHAR TÜRKMEN, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
Autres noms:
|
|
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Internal Jugular Vein Collapsibility Index (IJV-CI)
Délai: 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
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Baseline (pre-induction) and every minute up to 10 minutes following induction or until surgical in
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: ELZEM ŞEN, Associate Professor, Gaziantep University, Faculty of Medicine, Department of Anesthesiology and Reanimation
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026/217
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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