Non-invasive Cardiac Output Monitoring in Obstetric Patients

This study is currently recruiting participants.
Verified August 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01516697
First received: January 12, 2012
Last updated: August 2, 2012
Last verified: August 2012

January 12, 2012
August 2, 2012
October 2011
September 2012   (final data collection date for primary outcome measure)
Maximum percentage changes in mean blood pressure after spinal anesthesia [ Time Frame: baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia ] [ Designated as safety issue: Yes ]
changes in mean blood pressure (∆MBP) after spinal anesthesia [ Time Frame: baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01516697 on ClinicalTrials.gov Archive Site
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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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
  • Complications; Cesarean Section
  • Anesthesia; Adverse Effect, Spinal and Epidural
  • 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.
  • 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.
    Intervention: Procedure: Control
  • 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.
    Intervention: Procedure: experimental
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
No
Contact: Yandong Jiang, M.D., Ph.D. 617-447-9707 YJIANG@PARTNERS.ORG
Contact: Yanhong Liu, M.D., Ph.D. 617-724-4496 YLIU35@PARTNERS.ORG
United States
 
NCT01516697
2011-P-001449
No
Yandong Jiang, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Yandong Jiang, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP