- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: ELZEM ŞEN, Associate Professor
- Phone Number: +90 (532) 784 21 52
- Email: drelzem@hotmail.com
Study Contact Backup
- Name: KÜBRA BAHAR TÜRKMEN, MD
- Phone Number: +90 (534) 061 74 44
- Email: kbrabaharr@gmail.com
Study Locations
-
-
-
Gaziantep, Turkey (Türkiye), 27310
- Gaziantep University Sahinbey Research and Training Hospital
-
Contact:
- KÜBRA BAHAR TÜRKMEN, MD
- Phone Number: +90 (534) 061 74 44
- Email: kbrabaharr@gmail.com
-
Contact:
- ELZEM ŞEN, Associate Professor
- Phone Number: +90 (532) 784 21 51
- Email: drelzem@hotmail.com
-
Principal Investigator:
- ELZEM ŞEN, Associate Professor
-
Sub-Investigator:
- KÜBRA BAHAR TÜRKMEN, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
Other Names:
|
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Internal Jugular Vein Collapsibility Index (IJV-CI)
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ELZEM ŞEN, Associate Professor, Gaziantep University, Faculty of Medicine, Department of Anesthesiology and Reanimation
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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