Non-invasive Cardiac Output Monitoring in Obstetric Patients

NCT ID: NCT01516697

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-09-30

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.

Conditions

Complications; Cesarean Section; Anesthesia; Adverse Effect, Spinal and Epidural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Control

Intervention Type: PROCEDURE

Data obtained from the non-invasive cardiac output monitor,ICON®, are not available for the anesthesia care providers.

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.

Group Type: EXPERIMENTAL

experimental

Intervention Type: PROCEDURE

Non-invasive cardiac output monitoring using thoracic electric bioimpedance analysis via ICON® in addition of the standard monitoring during cesarean section.

Interventions

experimental

Non-invasive cardiac output monitoring using thoracic electric bioimpedance analysis via ICON® in addition of the standard monitoring during cesarean section.

Intervention Type: PROCEDURE

Control

Data obtained from the non-invasive cardiac output monitor,ICON®, are not available for the anesthesia care providers.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yandong Jiang

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yandong Jiang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2011-P-001449

Identifier Type: -

Identifier Source: org_study_id