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NCT01928797 · ClinicalTrials.gov registry record · NA
Ninvasive Cardiac Output Measurements During Cesarean Delivery Under Spinal Anesthesia.
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT01928797: Completed NA study, sponsored by Brigham and Women's Hospital.
NCT01928797 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928797, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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).
Primary Outcome
To determine mean cardiac output differences between the control group and the study group that used cardiac output data. In the control group, the cardiac output data was measured but not used for correcting blood pressure changes. Blood pressure changes were used for administering phenylephrine or ephedrine. In the study group, cardiac output data was used, in addition to blood pressure data, to correct both cardiac output and blood pressures to be maintained within 20% of baseline measurement
Interventions
- DEVICE Cardiac output monitor data
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-11-01 |
| Est. Completion | 2014-12-31 |
| Phase | NA |
What the finished NCT01928797 record still lists
NCT01928797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Cardiac output monitor data is the first listed.
NCT01928797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01928797 about?
NCT01928797 is a clinical study titled "Ninvasive Cardiac Output Measurements During Cesarean Delivery Under Spinal Anesthesia.". 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 bl...
What is the current status of trial NCT01928797?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2013-11-01. Estimated completion is 2014-12-31.
What interventions are being tested in trial NCT01928797?
The interventions under investigation include: Cardiac output monitor data (DEVICE).
Who is sponsoring clinical trial NCT01928797?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01928797's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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