Ninvasive Cardiac Output Measurements During Cesarean Delivery Under Spinal Anesthesia.
Completed · Not applicable
Conditions studied: Hypotension During Cesarean Delivery, Spinal Anesthesia
In brief
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).
Key facts
- Study ID
- NCT01928797
- Run by
- Brigham and Women's Hospital
- People needed
- 60
- Starts
- 2013-11-01
- Expected to finish
- 2014-12-31
- Last updated by the study team
- 2017-11-14
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Healthy pregnant subjects
You may not qualify if…
- Other than healthy
- High blood pressure. Presumed excessive bleeding, medications for blood pressure
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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