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Not yet recruitingNCT07496788Updated Mar 27, 2026

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

An observational study in Spinal Anesthesia-Induced Hypotension, Preeclampsia and Cesarean Section, sponsored by Ankara City Hospital Bilkent. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Ankara City Hospital Bilkent · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
96
Ages
18 Years to 45 Years
Sex
Female
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Study summary

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.

Read the 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.

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Conditions studied

  • Spinal Anesthesia-Induced Hypotension
  • Preeclampsia
  • Cesarean Section

Keywords

  • Preeclampsia
  • Spinal Anesthesia
  • Hypotension
  • Internal Jugular Vein
  • Collapsibility Index
  • Cesarean Section
  • Ultrasonography
  • Hemodynamic Monitoring
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In context

Pre-Eclampsia

883 studies on the registry are indexed under Pre-Eclampsia; 238 are open to participants now.

This study's planned enrollment of 96 is below the median of 160 across 381 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 425 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
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..

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
96 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

    Other: Internal Jugular Vein Collapsibility Index Measurement

Interventions

  • OtherInternal Jugular Vein Collapsibility Index Measurement

    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.

06

What researchers measure

Primary outcomes

  1. Predictive Value of Internal Jugular Vein Collapsibility Index for Spinal Anesthesia-Induced Hypotension

    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.

    Time frame: From spinal anesthesia administration to 20 minutes post-spinal anesthesia

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Study locations

1 site
  • Ankara Bilkent City Hospital
    Ankara, Ankara 06800, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07496788
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Nihan Aydin Guzey (Associate Professor Nihan Aydin Guzey, Ankara City Hospital Bilkent) — Principal investigator
First posted
Mar 27, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Jul 25, 2026 (estimated)
Completion
Jul 25, 2026 (estimated)
Last update
Mar 27, 2026

Study contacts

Nihan Aydin Guzey, MD, PhD
Contact
nihanaydinguzey@gmail.com
+905056496231
Basak Mizrak Demirbuken, MD
Contact
basakmizrak@gmail.com
+90509464248
Nihan Aydin Guzey, MD, PhD
principal investigator · Ankara City Hospital Bilkent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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