NCT05953129

Brief Summary

Jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) may be useful in estimating post spinal hypotension in cesarean section operations. Evaluation on the accuracy and effectiveness of these indices can contribute to the early diagnosis and management of hypotension. The main purpose of this study is to evaluate the effectiveness of shock indices in predicting the possibility of post spinal hypotension in cesarean section operations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 15, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

July 12, 2023

Last Update Submit

November 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prediction of hypotension

    To evaluate the ability of the jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) to predict post spinal hypotension in cesarean section surgeries.

    15 min

Interventions

Ultrasonography will be used to evaluate the diameter of the jugular vein (minimum and maximum values) and carotid diameter. The jugular vein collapsibility index will be measured by the anesthesiologist using non-invasive ultrasonography. Jugular vein collapsibility index will be calculated using the measured diameters.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women between the ages of 18-45 who were scheduled for cesarean section and who gave consent to participate in the study and to apply spinal anesthesia will be included in this study.

You may qualify if:

  • Pregnant women between the ages of 18-45 who had a planned cesarean section and approved to participate in the study and to apply spinal anesthesia

You may not qualify if:

  • Patients with Preeclampsia, Eclampsia, HELLP syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Training Research Hospital

Istanbul, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Specialist

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 19, 2023

Study Start

June 15, 2023

Primary Completion

October 15, 2023

Study Completion

October 30, 2023

Last Updated

December 3, 2025

Record last verified: 2025-11

Locations