Non-invasive Cardiac Output Monitoring in Obstetric Patients

NCT01516697 | Withdrawn Phase 4

• 1 other identifier: 2011-P-001449
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

thoracic electric bioimpedance; cardiac output monitoring; cesarean section; spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Maximum percentage changes in mean blood pressure after spinal anesthesia

  baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia

Study Arms (2)

Control

OTHER

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

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

Interventions

experimental PROCEDURE

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

experimental

Control PROCEDURE

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

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-45;
• receiving spinal anesthesia or combined spinal and epidural anesthesia to undergo cesarean section

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Yandong Jiang, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 25, 2012
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (1)