Non-invasive Cardiac Output Monitoring in Obstetric Patients
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.
Complications; Cesarean Section
Anesthesia; Adverse Effect, Spinal and Epidural
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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|
- 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 ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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.
Data obtained from the non-invasive cardiac output monitor,ICON®, are not available for the anesthesia care providers.
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.
Non-invasive cardiac output monitoring using thoracic electric bioimpedance analysis via ICON® in addition of the standard monitoring during cesarean section.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516697
|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, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Yandong Jiang, MD, PhD 617-447-9707 YJIANG@PARTNERS.ORG|
|Principal Investigator: Yandong Jiang, MD, PhD|
|Principal Investigator:||Yandong Jiang, MD, PhD||Massachusetts General Hospital|