- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: ELZEM ŞEN, Associate Professor
- Numero di telefono: +90 (532) 784 21 52
- Email: drelzem@hotmail.com
Backup dei contatti dello studio
- Nome: KÜBRA BAHAR TÜRKMEN, MD
- Numero di telefono: +90 (534) 061 74 44
- Email: kbrabaharr@gmail.com
Luoghi di studio
-
-
-
Gaziantep, Turchia (Türkiye), 27310
- Gaziantep University Sahinbey Research and Training Hospital
-
Contatto:
- KÜBRA BAHAR TÜRKMEN, MD
- Numero di telefono: +90 (534) 061 74 44
- Email: kbrabaharr@gmail.com
-
Contatto:
- ELZEM ŞEN, Associate Professor
- Numero di telefono: +90 (532) 784 21 51
- Email: drelzem@hotmail.com
-
Investigatore principale:
- ELZEM ŞEN, Associate Professor
-
Sub-investigatore:
- KÜBRA BAHAR TÜRKMEN, MD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
Altri nomi:
|
|
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Internal Jugular Vein Collapsibility Index (IJV-CI)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: ELZEM ŞEN, Associate Professor, Gaziantep University, Faculty of Medicine, Department of Anesthesiology and Reanimation
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026/217
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su IJV-CI Measurement
-
University Hospital, Basel, SwitzerlandCompletatoDisidratazione | Ipervolemia | Disturbi dell'equilibrio idricoSvizzera
-
Suez Canal UniversityReclutamentoComplicanze postoperatorieEgitto
-
MediBeaconNon ancora reclutamentoVelocità di filtrazione glomerulareStati Uniti
-
National Taiwan University HospitalAttivo, non reclutanteTrombosi venosa | Infezioni correlate al catetere | Tasso di guasto meccanico del catetereTaiwan
-
Assiut UniversityNon ancora reclutamento
-
Keimyung University Dongsan Medical CenterCompletatoSicurezza del paziente durante il cateterismo venoso centraleCorea, Repubblica di
-
Kasr El Aini HospitalCompletatoAnestesia | Ultrasuoni | Catetere venoso centrale | Pediatrico | Vena giugulare internaEgitto
-
Cairo UniversityCompletato