Body Impedance Method in Patients Undergoing Urgent and Elective Cesarian Section

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

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.

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Diagnostic test: non invasive whole body bioimpedence system

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 95

Contacts and Locations

• Study Contact: Name: Zuhal Cavus, MD; Phone Number: +902124041500; Email: zuhalcavus74@gmail.com
• Study Contact Backup: Name: Zuhal Cavus, Cavus; Phone Number: +902124041500; Email: zuhalcavus74@gmail.com

Study Locations

• Turkey
  • Gaziosmanpaşa
    • Istanbul, Gaziosmanpaşa, Turkey, 34255
      • Recruiting
      • Gaziosmanpaşa TREH
      • Contact: aygen türkmen, MD.prof.; Phone Number: +902129453000; Email: aygenturkmen@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Emergency or elective cesarean patients, which are between 18-45 years of age

Description

Inclusion Criteria:

• Must be scheduled for elective or emergency cesarean section

Exclusion Criteria:

• History of cardiac surgery, and advanced cardiac valvular disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Bioimpedence; Noninvasive hemodynamic changes will be observed by using whole-body impedance method urgent or elective cesarian section patients under general anesthesia.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Actual): June 5, 2020
• Study Completion (Anticipated): June 10, 2021

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Zuhal1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No