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Ninvasive Cardiac Output Measurements During Cesarean Delivery Under Spinal Anesthesia.

NCT01928797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-11-14

Study results available
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Summary

The purpose of the study is to learn more about how the heart works during cesarean delivery under spinal anesthesia (medicines given in the spine that numb parts of your body to block pain) in women. The investigators would like to find out if the information about the heart can help in treating blood pressure changes that occur during the cesarean delivery. The investigators would also like to find out if this information can help reduce the chances of nausea and vomiting during the cesarean delivery.

The activity of the heart changes during spinal anesthesia and cesarean section. In the past, a sensor placed directly into the heart was the only way to see how the heart worked. Currently, there are monitors that can sense the heart's activity via sensors that are placed on the skin during cesarean delivery.

In this study, the investigators will use the ICON cardiac output (ICON) monitor. The ICON monitor is approved by the US Food and Drug Administration (FDA) to monitor (check) the activity of your heart.

This study aims to:

1. Determine if additional cardiac output measurements help anesthesiologists maintain appropriate hemodynamics as defined as within 20% of baseline BP and if it changed their choice of vasopressors (primary outcome).
2. Determine if additional cardiac output measurements help to decrease the incidence of nausea and vomiting during cesarean delivery (secondary outcome).

Conditions

  • Hypotension During Cesarean Delivery
  • Spinal Anesthesia

Interventions

DEVICE

Cardiac output monitor data

The availability of cardiac output monitor provides additional hemodynamic indices that may help guide anesthesiologists to better select vasopressors

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Bhavani Shankar Kodali, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-01
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01928797 on ClinicalTrials.gov