N/A Completed N=60 Randomized Treatment

Ninvasive Cardiac Output Measurements During Cesarean Delivery Under Spinal Anesthesia.

Hypotension During Cesarean Delivery · Spinal Anesthesia

Source: ClinicalTrials.gov NCT01928797 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2017

Primary outcomePrimary: Percentage of Participants With a Cardiac Output Within and Outside 20% of Baseline Values — 71; 66; 29; 34 percentage of patients — p=0.37

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With a Cardiac Output Within and Outside 20% of Baseline Values	71; 66; 29; 34	0.37
SECONDARY Nausea and Vomiting	1; 1; 9; 9	0.33
SECONDARY Number of Participants With Umbilical Cord pH	1; 0	—

Eligibility Criteria

Inclusion Criteria

Healthy pregnant subjects

Exclusion Criteria

Other than healthy
High blood pressure. Presumed excessive bleeding, medications for blood pressure

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Data sourced from ClinicalTrials.gov (NCT01928797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.