Investigation of the Role of Internal Jugular Vein Collapsibility Index in Predicting Spinal Anesthesia-Induced Hypotension in Preeclamptic Parturients

March 23, 2026 updated by: Nihan Aydin Guzey, Ankara City Hospital Bilkent
This prospective, single-center observational study aims to evaluate the predictive value of the internal jugular vein collapsibility index (IJVCI) for spinal anesthesia-associated hypotension in preeclamptic parturients (gestational age ≥28 weeks) undergoing cesarean delivery classified as Lucas category 3-4. Preoperative IJVCI will be measured using ultrasonography before spinal anesthesia during spontaneous and deep respiration. The incidence of hypotension within the first 20 minutes after spinal anesthesia will be recorded. The diagnostic performance of IJVCI in predicting hypotension will be analyzed.

Study Overview

Detailed Description

This prospective, single-center observational study is designed to evaluate the predictive value of the internal jugular vein collapsibility index (IJVCI) for spinal anesthesia-associated hypotension in preeclamptic parturients undergoing cesarean delivery classified as Lucas category 3-4.

Eligible patients aged 18-45 years with ASA physical status II-III and singleton pregnancies at ≥28 weeks of gestation will be enrolled. Preoperative ultrasonographic measurements of the right internal jugular vein will be performed to calculate IJVCI using M-mode imaging. Maximum and minimum diameters during spontaneous and deep respiration will be recorded.

Spinal anesthesia will be performed with hyperbaric bupivacaine. Hemodynamic parameters (systolic, diastolic and mean arterial pressure, heart rate, and oxygen saturation) will be monitored with blood pressure measurements every 2 minutes during the first 20 minutes and then every 5 minutes thereafter. Hypotension will be defined as a ≥30% decrease in mean arterial pressure from baseline or systolic blood pressure <100 mmHg. Hypotension will be treated according to the study protocol with ephedrine boluses as needed.

The primary outcome is the incidence of spinal anesthesia-associated hypotension within the first 20 minutes after spinal anesthesia. Secondary outcomes include total ephedrine consumption, number and duration of hypotensive episodes, estimated blood loss, and neonatal outcomes (Apgar scores). The diagnostic performance of IJVCI will be evaluated using receiver operating characteristic (ROC) curve analysis.

Study Type

Observational

Enrollment (Estimated)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06800
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women diagnosed with preeclampsia who are scheduled for cesarean delivery under spinal anesthesia at Ankara Bilkent City Hospital, with cesarean urgency classified as Lucas category 3-4. Eligible participants are aged 18-45 years, have ASA physical status II-III, and have a gestational age ≥28 weeks. Participants will be evaluated for the development of spinal anesthesia-associated hypotension within the first 20 minutes after spinal anesthesia..

Description

Inclusion Criteria:

  • Age between 18 and 45 years
  • ASA physical status II-III
  • Diagnosed with preeclampsia
  • Scheduled for cesarean delivery under spinal anesthesia with cesarean urgency classified as Lucas category 3-4
  • Gestational age ≥28 weeks
  • Provided written informed consent

Exclusion Criteria:

  • Cesarean urgency classified as Lucas category 1-2
  • Gestational age <28 weeks
  • ASA physical status ≥ IV
  • Known renal disease
  • Cardiac instability or known arrhythmia
  • Requirement of general anesthesia or sedation
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preeclamptic Parturients Undergoing Cesarean Section
Preeclamptic pregnant women aged 18-45 years with ASA physical status II-III and gestational age ≥28 weeks who are scheduled for cesarean delivery under spinal anesthesia, with cesarean urgency classified as Lucas category 3-4. Preoperative internal jugular vein collapsibility index (IJVCI) will be measured using ultrasonography before spinal anesthesia, and participants will be followed for the development of spinal anesthesia-associated hypotension within the first 20 minutes after spinal anesthesia.
Preoperative ultrasonographic measurement of the internal jugular vein collapsibility index (IJVCI) performed before spinal anesthesia in preeclamptic parturients (gestational age ≥28 weeks) undergoing cesarean delivery classified as Lucas category 3-4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive Value of Internal Jugular Vein Collapsibility Index for Spinal Anesthesia-Induced Hypotension
Time Frame: From spinal anesthesia administration to 20 minutes post-spinal anesthesia
Diagnostic performance of the preoperative internal jugular vein collapsibility index (IJVCI) for predicting spinal anesthesia-associated hypotension within the first 20 minutes after spinal anesthesia, assessed by receiver operating characteristic (ROC) curve analysis. Hypotension will be defined as a ≥30% decrease in mean arterial pressure from baseline or systolic blood pressure <100 mmHg.
From spinal anesthesia administration to 20 minutes post-spinal anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nihan Aydin Guzey, MD, PhD, Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 25, 2026

Study Completion (Estimated)

July 25, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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