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

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.

Study Overview

• Status: Withdrawn
• Conditions: Complications; Cesarean Section; Anesthesia; Adverse Effect, Spinal and Epidural
• Intervention / Treatment: Procedure: Control; Procedure: experimental

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Control; 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.	Procedure: Control; Data obtained from the non-invasive cardiac output monitor,ICON®, are not available for the anesthesia care providers.
EXPERIMENTAL: experimental; 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.	Procedure: experimental; Non-invasive cardiac output monitoring using thoracic electric bioimpedance analysis via ICON® in addition of the standard monitoring during cesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ANTICIPATED): September 1, 2012
• Study Completion (ANTICIPATED): September 1, 2012

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (ESTIMATE): January 25, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 15, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: cesarean section; spinal anesthesia; cardiac output monitoring; thoracic electric bioimpedance
• Other Study ID Numbers: 2011-P-001449