Body Impedance Method in Patients Undergoing Urgent and Elective Cesarian Section

Cesarean Section Complications Clinical Trial

Official title:

Noninvasive Evaluation of Hemodynamics by Using Body Impedance Method in Patients Undergoing Urgent and Elective Cesarian Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04230525
• Other study ID #: Zuhal1
• Status: Recruiting
• Start date: March 5, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: June 2020
• Source: Gaziosmanpasa Taksim Research and Education Hospital
• Contact: Zuhal Cavus, MD
• Phone: +902124041500
• Email: zuhalcavus74[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Independent form anesthetic methods, during C/S, considering both maternal and fetal conditions, some crucial hemodynamic changes can appear and can be claimed non invasively with the whole body bioimpedance. In this research, any kind of hemodynamic difference between this method and urgent or elective C/S case will be detected and the clinic pursuit can be developed creating an advantage in favor of both maternal and fetal conditions.

Description:

Independent form anesthetic methods, during C/S, considering both maternal and fetal conditions, some crucial hemodynamic changes can appear and can be claimed non invasively with the whole body bioimpedance. In this research, any kind of hemodynamic difference between this method and urgent or elective C/S case will be detected and the clinic pursuit can be developed creating an advantage in favor of both maternal and fetal conditions. Under general anesthesia, measuring the hemodynamic changes with the method of non-invasive whole-body bioimpedance system during C/S.

Detection of in which phase of operations the potential changes densify and differences between urgent and elective conditions non invasively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: June 10, 2021
• Est. primary completion date: June 5, 2020
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Must be scheduled for elective or emergency cesarean section

Exclusion Criteria:

• History of cardiac surgery, and advanced cardiac valvular disease

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Diagnostic Test:
• non invasive whole body bioimpedence system
Noninvasive hemodynamic changes will be observed by using whole-body impedance method urgent or elective cesarian section patients under general anesthesia. The whole-body bioimpedance method will be used to monitör the hemodynamic changes non invasively. This method can evaluate such as cardiac output, cardiac index, stroke volüme, stroke index, stroke volüme variations, cardiac reserve, etc. Parameters with a completely noninvasive method by using only electrots. The device consists of a laptop, a software which calculates cardiac parameters and two electrodes. The measurement is done by the following process: one of these electrodes, which looks like ECG electrodes, is stuck to the wrist and the other one to the opposite ankle or each one to two wrists.

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa TREH	Istanbul	Gaziosmanpasa

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Taksim Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAP	The difference in mean arterial pressure during the cesarean section between elective and emergency ceasreansection subjects	1, 5, 15, and 30 minutes following the induction of the anesthesia