Non-invasive Cardiac Output Monitoring in Obstetric Patients

Complications; Cesarean Section Clinical Trial

Official title:

Using Thoracic Electrical Bioimpedance to Measure Stroke Volume and Cardiac Output in Patients Under Spinal Anesthesia for Cesarean Section

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01516697
• Other study ID #: 2011-P-001449
• Status: Withdrawn
• Phase: Phase 4
• First received: January 12, 2012
• Last updated: January 15, 2017
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• experimental
Non-invasive cardiac output monitoring using thoracic electric bioimpedance analysis via ICON® in addition of the standard monitoring during cesarean section.
• Control
Data obtained from the non-invasive cardiac output monitor,ICON®, are not available for the anesthesia care providers.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum percentage changes in mean blood pressure after spinal anesthesia		baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia