Ninvasive Cardiac Output Measurements During Cesarean Delivery Under Spinal Anesthesia.

NCT01928797 | Completed Results

• 1 other identifier: 2013-p-001314
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Keywords

cardiac output pregnancy spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Cardiac Output Within and Outside 20% of Baseline Values

  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 measurements. After spinal anesthesia for cesarean delivery, the cardiac output and blood pressure tends to decrease. When this occurs, the blood flow to the uterus and the baby decrease resulting in fetal heart changes. Since we do not monitor the baby during the actual cesarean delivery (technically difficult), the strategy is to maintain the blood pressure and cardiac output within the 20% of the baseline values.

  intraoperatively during surgery

Secondary Outcomes (2)

• Nausea and Vomiting

  intraoperatively during surgery

• Number of Participants With Umbilical Cord pH

  Intraoperative

Study Arms (2)

Control group

NO INTERVENTION

The care provider will use blood pressure and heart rate data to administer vasopressor use. In the control group, vasopressors (phenylephrine and ephedrine) will be used as considered appropriate to maintain BP within 20% of baseline. The CO data is measured and blinded to the anesthesiologists in the control group, therefore the anesthesiologist choice of ephedrine or phenylephrine is based on the individual anesthesiologist standard of care preference

Study group

EXPERIMENTAL

The care provider will use the cardiac output monitor data (intervention) to guide vasopressors (Phenylephrine and ephedrine) in addition to blood pressure and heart rate data based on a standardized protocol in addition to the blood pressure and heart rate data available in the control group.

Device: Cardiac output monitor data

Interventions

Cardiac output monitor data DEVICE

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

Study group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02090, United States

Location

Results Point of Contact

• Title: Dr. Bhavani Kodali
• Organization: Brigham and Women's Hospital

BKODALI@BWH.HARVARD.EDU

617-732-8220

Study Officials

• Bhavani Shankar Kodali, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The investigator assigned the subject to one of the groups. Care provided followed the protocol for the group and the investigator analyzed the outcome results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Anesthesiology

Model Details: Investigator randomly assigns the subjects into one of the two groups. Control group and Interventional group

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: August 27, 2013
• Study Start: November 1, 2013
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: November 14, 2017
• Results First Posted: September 26, 2017

Record last verified: 2017-10

Locations

US (1)