CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
NICaS Bio Impedancedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02902068
NCT02902068N/ACompleted

Maternal Hemodynamic Monitoring in Women Undergoing Cesarean Section by Use of NICaS Cardiac Impedance

Rabin Medical Center·observational·Posted Sep 15, 2016·Updated Mar 29, 2019

In Brief

An observational study evaluating NICaS Bio Impedance for Hemodynamics. Completed, enrolled 200 participants across 1 site.

Detailed Summary

In this study we would like to monitor cardiac output by the use of NICAS bioimpedance in women undergoing cesarean section delivery. This study is a purely observational study, it will not have any clinical intervention nor will it interfere with standard cesarean delivery protocols in any way. This study's primary objective is to evaluate how spinal and general anesthesia influences cardiac output during cesarean section deliveries. Secondary endpoints is whether the hemodynamic changes as measured in cardiac output correlate with women's pain, measured by a visual analogue scale(VAS) from o-10. (0=representing no pain at all, 10= worse pain imaginable)

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHemodynamics
CountriesIsrael
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 15, 2016
Enrollment StartMay 1, 2016
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.8 years ago

Interventions

NICaS Bio Impedancedevice

Hemodynamic monitoring will be carried out using non invasive NICaS cardiac impedance by the use of two electrodes stickers which are pasted on the wrists for about 6 minutes. Monitoring will be done with women lying down or sitting up half an hour preoperatively (in the woman's surgery waiting room) intraoperatively, and postoperatively in the PACU. Preoperative data will be compared to intraoperative and postoperative data, and will be analyzed in order to evaluate the dynamic cardiac output changes in women undergoing cesarean sections.