Non-invasive Cardiac Output Monitoring in Obstetric Patients

Mass General Brigham

Status and phase: Withdrawn; Phase 4

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

Treatments: Procedure: experimental; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01516697

2011-P-001449

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Control

Other group

Description:

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.

Treatment:

Procedure: Control

experimental

Experimental group

Description:

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.

Treatment:

Procedure: experimental