Non-invasive Cardiac Output Monitoring in Obstetric Patients

Recruiting

Phase 4 Results N/A

Trial Description

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

Interventions

  • Experimental Other
    Intervention Desc: Non-invasive cardiac output monitoring using thoracic electric bioimpedance analysis via ICON® in addition of the standard monitoring during cesarean section.
    ARM 1: Kind: Experimental
    Label: experimental
    Description: The patients in Group B will receive the same monitoring as those in Group A. But the physicians will know instantaneously the CO and SV in real time and will manage the patients accordingly.
  • Control Device
    Intervention Desc: Data obtained from the non-invasive cardiac output monitor,ICON®, are not available for the anesthesia care providers.
    ARM 1: Kind: Experimental
    Label: Control
    Description: The patients in Group A will serve as controls and will receive standard monitoring in addition to continuous measurement of SV and CO. The physicians will not know the CO and SV and will manage the patients in a standard fashion.
  • ICON Device
    Other Names: ICON® (Cardiotronic®, La Jolla, California)
    Intervention Desc: Non-invasive cardiac output monitoring using thoracic electric bioimpedance analysis via ICON® in addition of the standard monitoring during cesarean section.
    ARM 1: Kind: Experimental
    Label: Control
    Description: The patients in Group A will serve as controls and will receive standard monitoring in addition to continuous measurement of SV and CO. The physicians will not know the CO and SV and will manage the patients in a standard fashion.
    ARM 2: Kind: Experimental
    Label: Experimental
    Description: The patients in Group B will receive the same monitoring as those in Group A. But the physicians will know instantaneously the CO and SV in real time and will manage the patients accordingly.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Diagnostic
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary changes in mean blood pressure (∆MBP) after spinal anesthesia baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia Yes
Primary Maximum percentage changes in mean blood pressure after spinal anesthesia baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia Yes

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