Non-invasive Cardiac Output Monitoring in Obstetric Patients

Phase 4

Withdrawn

• Conditions: Anesthesia; Adverse Effect, Spinal and Epidural; Complications; Cesarean Section
• Interventions: Procedure: Control; Procedure: experimental

• Registration Number: NCT01516697
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-25
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-15
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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.
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.

Primary Outcome Measures

Name	Time	Method
Maximum percentage changes in mean blood pressure after spinal anesthesia	baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States