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
1 other identifier
observational
95
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
1 active site
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
First Submitted
Initial submission to the registry
January 13, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
March 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2021
CompletedMarch 8, 2021
June 1, 2020
3 months
January 13, 2020
March 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Bioimpedence
Noninvasive hemodynamic changes will be observed by using whole-body impedance method urgent or elective cesarian section patients under general anesthesia.
Interventions
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.
Eligibility Criteria
Emergency or elective cesarean patients, which are between 18-45 years of age
You may qualify if:
- Must be scheduled for elective or emergency cesarean section
You may not qualify if:
- History of cardiac surgery, and advanced cardiac valvular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziosmanpaşa TREH
Istanbul, Gaziosmanpaşa, 34255, Turkey (Türkiye)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, M.D.
Study Record Dates
First Submitted
January 13, 2020
First Posted
January 18, 2020
Study Start
March 5, 2020
Primary Completion
June 5, 2020
Study Completion
June 10, 2021
Last Updated
March 8, 2021
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share