- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07539896
The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
Spinal anesthesia is widely preferred for elective cesarean delivery due to its favorable safety profile and superior postoperative analgesia. However, post-spinal hypotension (PSH) remains a common complication, with reported incidence rates ranging from 40% to 70%, potentially compromising maternal hemodynamic stability and uteroplacental perfusion. Early identification of patients at high risk for PSH is therefore of critical clinical importance.
This prospective observational study aims to evaluate the predictive performance of preoperative internal jugular vein collapsibility index (IJV-CI), assessed by ultrasonography, and baseline perfusion index (PI), obtained via pulse oximetry, for the development of PSH in patients undergoing elective cesarean section under spinal anesthesia. While IJV-CI reflects intravascular volume status and preload, PI represents peripheral vascular tone; thus, their combined use may improve predictive accuracy.
Study Design This is a single-center, prospective observational study conducted in patients scheduled for elective cesarean delivery under spinal anesthesia. No additional intervention will be applied, and all anesthetic management will follow standard clinical practice.
Objectives
Primary Objective:
To assess the ability of preoperative IJV collapsibility index (IJV-CI) and baseline perfusion index (PI) to predict post-spinal hypotension.
Secondary Objectives:
To evaluate the relationship between IJV-CI and PI with:
Duration and number of hypotensive episodes Minimum systolic and mean arterial pressure Total vasopressor requirement Incidence of intraoperative nausea and vomiting Pregnant women aged 18-45 years, ASA II, with singleton pregnancies scheduled for elective cesarean section under spinal anesthesia.
Inclusion Criteria Age 18-45 years Elective cesarean section Planned spinal anesthesia ASA physical status II Singleton pregnancy Exclusion Criteria Hypertensive disorders of pregnancy (e.g., preeclampsia, HELLP) Significant cardiac or pulmonary disease Chronic kidney disease Multiple pregnancy Emergency cesarean delivery Conversion to general anesthesia
Conditions preventing IJV ultrasonographic assessmentBaseline PI will be recorded preoperatively using standard pulse oximetry. IJV diameters will be measured via ultrasound, and the collapsibility index will be calculated as:
IJVI: (Dmax-Dmin/Dmax)X100 Hemodynamic parameters will be recorded at 3-minute intervals from spinal anesthesia administration until delivery. Statistical analysis will include ROC curve analysis, correlation analysis, and logistic regression to evaluate predictive performance.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Özlem Şen
- Phone Number: +90 (506) 359 1751
- Email: turanozlem1@yahoo.com.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Age 18-45 years Singleton pregnancy Scheduled for elective cesarean section Planned spinal anesthesia ASA physical status II
Exclusion Criteria:
Hypertensive disorders of pregnancy (e.g., preeclampsia, HELLP syndrome) Known significant cardiac disease or pulmonary hypertension Chronic kidney disease Hemoglobinopathies Multiple pregnancy Emergency cesarean section Conversion to general anesthesia Anatomical or pathological conditions preventing IJV ultrasound assessment -
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post- Spinal Hypotension
Time Frame: From spinal anesthesia administration until delivery
|
Occurrence of Post-Spinal Hypotension Defined as a ≥20% decrease in mean arterial pressure (MAP) from baseline.
|
From spinal anesthesia administration until delivery
|
Collaborators and Investigators
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
Other Study ID Numbers
- Muğla Training and Research Ho
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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