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Ninvasive Cardiac Output Measurements During Cesarean Delivery Under Spinal Anesthesia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928797
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : September 26, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Bhavani Shankar Kodali, Brigham and Women's Hospital

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. 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).

Condition or disease Intervention/treatment Phase
Hypotension During Cesarean Delivery Spinal Anesthesia Device: Cardiac output monitor data Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Investigator randomly assigns the subjects into one of the two groups. Control group and Interventional group
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: To Determine if the Cardiac Output Monitoring During Cesarean Delivery Under Spinal Anesthesia Will Change Our Clinical Practice of Using Vasopressors
Study Start Date : November 1, 2013
Actual Primary Completion Date : December 31, 2014
Actual Study Completion Date : December 31, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
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
Experimental: Study group
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
The availability of cardiac output monitor provides additional hemodynamic indices that may help guide anesthesiologists to better select vasopressors




Primary Outcome Measures :
  1. Percentage of Participants With a Cardiac Output Within and Outside 20% of Baseline Values [ Time Frame: intraoperatively during surgery ]

    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.



Secondary Outcome Measures :
  1. Nausea and Vomiting [ Time Frame: intraoperatively during surgery ]
    incidence of nausea, and vomiting

  2. Number of Participants With Umbilical Cord pH [ Time Frame: Intraoperative ]
    Number of participants with Umbilical cord pH <7.2



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy pregnant subjects

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928797


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02090
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Bhavani Shankar Kodali, MD Brigham and Women's Hospital
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Responsible Party: Bhavani Shankar Kodali, Vice Chair, Anesthesiology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01928797    
Other Study ID Numbers: 2013-p-001314
First Posted: August 27, 2013    Key Record Dates
Results First Posted: September 26, 2017
Last Update Posted: November 14, 2017
Last Verified: October 2017
Keywords provided by Bhavani Shankar Kodali, Brigham and Women's Hospital:
cardiac output pregnancy spinal anesthesia
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases