Non-invasive Cardiac Output Monitoring in Obstetric Patients

Using Thoracic Electrical Bioimpedance to Measure Stroke Volume and Cardiac Output in Patients Under Spinal Anesthesia for Cesarean Section

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01516697

Enrollment

Registered

2012-01-25

Start date

2011-10-31

Completion date

2012-09-30

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia; Adverse Effect, Spinal and Epidural, Complications; Cesarean Section

Keywords

thoracic electric bioimpedance, cardiac output monitoring, cesarean section, spinal anesthesia

Brief summary

The investigators hypothesize that continuously measuring stroke volume (SV) and cardiac output (CO) will 1) reveal hemodynamic instability in a timely manner and alert the physician promptly, 2) provide information for the physician to make the differential diagnosis as to whether the hemodynamic instability was due to vasodilatation or reduction of venous blood return, and 3) lead to appropriate and prompt treatment to improve patient outcome. -determine the SV and CO and their kinetic change using ICON® to establish a hemodynamic profile of the patient under spinal anesthesia for cesarean section. To determine if using instantaneous measurements of SV and CO to guide patient management improves hemodynamic stability.

Interventions

PROCEDUREexperimental

Non-invasive cardiac output monitoring using thoracic electric bioimpedance analysis via ICON® in addition of the standard monitoring during cesarean section.

PROCEDUREControl

Data obtained from the non-invasive cardiac output monitor,ICON®, are not available for the anesthesia care providers.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* age 18-45; * receiving spinal anesthesia or combined spinal and epidural anesthesia to undergo cesarean section

Exclusion criteria

* Patients who have major cardiovascular disease,preexisting of hypertension or gestational hypertension, preeclampsia and body mass index greater than 35kg/m2; * Patients who have skin lesion at the place where the electrode is supposed to be applied; * Emergency cesarean section patients.

Design outcomes

Primary

Measure	Time frame
Maximum percentage changes in mean blood pressure after spinal anesthesia	baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026