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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05953129
Other study ID # 126
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 15, 2023
Est. completion date September 30, 2023

Study information

Verified date July 2023
Source Gaziosmanpasa Research and Education Hospital
Contact Oguz Ozakin, MD
Phone 00905437936786
Email oguzozakin@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date September 30, 2023
Est. primary completion date September 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients with Preeclampsia, Eclampsia, HELLP syndrome

Study Design


Intervention

Diagnostic Test:
Right Jugular Vein Collapsibility Index
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.

Locations

Country Name City State
Turkey Gaziosmanpasa Training Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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