Non-invasive Cardiac Output Monitoring in Obstetric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01516697
Recruitment Status : Withdrawn (unable to enrollment subjects due to early departure of study personele)
First Posted : January 25, 2012
Last Update Posted : January 18, 2017
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Complications; Cesarean Section Anesthesia; Adverse Effect, Spinal and Epidural Procedure: experimental Procedure: Control Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Using Thoracic Electrical Bioimpedance to Measure Stroke Volume and Cardiac Output in Patients Under Spinal Anesthesia for Cesarean Section
Study Start Date : October 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Maximum percentage changes in mean blood pressure after spinal anesthesia [ Time Frame: baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01516697

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Yandong Jiang, MD, PhD Massachusetts General Hospital

Responsible Party: Yandong Jiang, Assistant professor, Massachusetts General Hospital Identifier: NCT01516697     History of Changes
Other Study ID Numbers: 2011-P-001449
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Yandong Jiang, Massachusetts General Hospital:
thoracic electric bioimpedance
cardiac output monitoring
cesarean section
spinal anesthesia