NCT07565025

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Feb 2027

First Submitted

Initial submission to the registry

April 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Internal Jugular VeinCollapsibility IndexIJV-CIUltrasonographyPost-induction HypotensionAnesthesia InductionLaparoscopic CholecystectomyFluid Responsiveness

Outcome Measures

Primary Outcomes (1)

  • Internal Jugular Vein Collapsibility Index (IJV-CI)

    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

Study Arms (2)

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.

Diagnostic Test: IJV-CI Measurement

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."

Diagnostic Test: IJV-CI Measurement

Interventions

IJV-CI MeasurementDIAGNOSTIC_TEST

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.

Also known as: IJV-CI, Internal Jugular Vein Collapsibility Index, IJV Ultrasonography
Hypotensive GroupNon-hypotensive Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University Sahinbey Research and Training Hospital

Gaziantep, 27310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • ELZEM ŞEN, Associate Professor

    Gaziantep University, Faculty of Medicine, Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ELZEM ŞEN, Associate Professor

CONTACT

Kübra Bahar Türkmen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations