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Non-invasive Cardiac Output Monitoring in Obstetric Patients

NCT01516697 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-01-18

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

experimental

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

PROCEDURE

Control

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Yandong Jiang, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01516697 on ClinicalTrials.gov