Non-invasive Cardiac Output Monitoring in Obstetric Patients
This study is currently recruiting participants.
Verified August 2012 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Complications; Cesarean Section Anesthesia; Adverse Effect, Spinal and Epidural |
Procedure: experimental Procedure: Control |
Phase 4 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 40 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516697
Contacts
| 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 |
Locations
| 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 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Yandong Jiang, MD, PhD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Yandong Jiang, Assistant professor, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01516697 History of Changes |
| Other Study ID Numbers: | 2011-P-001449 |
| Study First Received: | January 12, 2012 |
| Last Updated: | August 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
thoracic electric bioimpedance cardiac output monitoring cesarean section spinal anesthesia |
Additional relevant MeSH terms:
|
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013