A Prospective Study of a New Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Charles Cote, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01499615
First received: December 20, 2011
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

Traditionally cardiac output has been estimated with thermodilution. Recently a new device non-invasive (Cardiotronic® EC™)devicehas been approved by the FDA for use in children of all ages including neonates (just 4 EKG electrodes). Primary outcome: To prospectively collect simultaneous physiologic data for all enrolled children by transferring the data from the investigators computerized anesthesia records to Excel spreadsheets and to correlate adverse events across monitoring devices.

Secondary outcomes: To determine if the device provides meaningful data in terms of an early warning of decreased cardiac output in specific subgroups of children undergoing surgery and anesthesia, e.g., neonates, trauma patients, children with congenital heart disease, those undergoing procedures with expected blood loss, those undergoing laparoscopic procedures where gas insufflation may impede venous return to the heart.


Condition
Children Undergoing Anesthesia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study of a New Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Correlate adverse cardiovascular events in children under anesthesia with the cardiac output device and standard anesthesia monitors [ Time Frame: approximately 18 months ] [ Designated as safety issue: Yes ]
    We plan to record all physiologic data from approximately 400 children under anesthesia and correlate adverse cardiovascular events determined by this new cardiac output device with standard anesthesia monitors


Secondary Outcome Measures:
  • determine if this device provides additonal safety for specific subgroups of pediatric patients under anesthesia e.g., those undergoing laparosopic procedures or procedures involving significant blood loss, neonates [ Time Frame: approximatley 18 months ] [ Designated as safety issue: Yes ]
    determine is some subgroups within the proposed 400 cases derive specific benefit from this additional non-invasive monitor, i.e., an early warning of impaired cardiac output or a correlation with decreased blood pressure with decreased cardiac output. The issue is whether cardiac out updated at approximate 20 second intervals can provide an eralier warning than the standard 3 to 5 minute blood pressures provided by non-invasive blood pressure monitroing which is the standard of care.


Estimated Enrollment: 400
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Detailed Description:

All children undergoing both elective and emergent surgery or GI endoscopy evaluation will be candidates for study. Since this is an FDA approved monitor that is approved across all age groups and since this is an additional monitor over those routinely used in the operating room and since it is noninvasive(4 EKG leads)verbal consent documented in the record has been approved by the IRB.

After informed verbal consent, either the research coordinator or a study physician will populate the cardiac output device with the child's age, weight, gender and height. For older children the required 4 EKG electrodes will be applied prior to induction of anesthesia (2 on the left side of the neck and 2 on the left chest at the level of the sternal depression; for neonates and infants one electrode can be applied to the forehead and the other to a thigh if application space is a problem). For children who are not able to be cooperative, as with most of our monitors the electrodes will be placed after induction of general anesthesia. An automated anesthesia record will continuously record heart rate, respiratory rate, oxygen saturation, systolic and diastolic pressures. The monitor will be set to perform these measurements every 1 minute. New software has been written that enables us to interface the cardiac output device with our automated anesthesia record. Thus the data from the cardiac output device will be inserted on the anesthesia record at approximate 1 minute intervals in real time. The data from the anesthesia records will later be downloaded as a unit to Excel spread sheets for later analysis. All demographic data will also be downloaded (age, weight, ASA physical status,surgical procedure) as well as blood loss and blood and fluid administered as well as drugs,significant intraoperative events, and the timing of events as they evolve. All data will be entered on a Partners password protected computer. Initially the patient's medical record number which links us to the Metavision anesthesia record will be recorded as this allows us to download the data. Patient names will not be downloaded. Once the data set is completed,analyzed and locked, the medical record number will be removed so that no identifiers will remain. The data will not be shared with any other institution. Only deidentified data will remain on the final data base

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

neonates to teenagers

Criteria

Inclusion Criteria:

  • All children presenting to our operating rooms for general anesthesia

Exclusion Criteria:

  • Cardiac surgery, open chest procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499615

Contacts
Contact: Charles J Cote, MD 617 726 2607 cjcote@partners.org

Locations
United States, Massachusetts
Operating rooms and GI endoscopy suites of the Massachusetts GeneralHospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Charles J Cote, MD    617-726-2607    cjcote@partners.org   
Sub-Investigator: Paul Firth, MB ChB         
Sub-Investigator: Lucinda Everett, MD         
Sub-Investigator: Gennadiy Fuzaylov, MD         
Sub-Investigator: Somaletha Bhattacharya, MD         
Sub-Investigator: Erik Shank, MD         
Sub-Investigator: Pacificao Tuason, MD         
Sub-Investigator: Audrius Zibaitis, MD         
Sub-Investigator: Anthony Anderson, MD         
Sub-Investigator: David Maduram, MD         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Charles Cote, Director of Clinical Research, Divisionof Pediatric Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01499615     History of Changes
Other Study ID Numbers: 2010-P-002709/1; MGH
Study First Received: December 20, 2011
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
adverse events
adverse cardiovascular events
early warning

ClinicalTrials.gov processed this record on September 18, 2014