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Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation (DEX-CO)

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ClinicalTrials.gov Identifier: NCT01001533
Recruitment Status : Completed
First Posted : October 26, 2009
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jackson Wong, Boston Children's Hospital

Study Description
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Brief Summary:
The aim of the study is to investigate the use of a new FDA-approved non-invasive bio-impedance cardiac monitor, ICON, to detect hemodynamic effects during sedation in children undergoing radiology procedures. The purpose of the study is to determine the ability of the ICON monitor to identify the anticipated and documented hemodynamic changes in children which occur in response to Dexmedetomidine sedation. The investigators postulate that if the ICON device can trend hemodynamic changes, if any, during dexmedetomidine (DEX) sedation in children the investigators can delineate changes in cardiac output, stroke volume, and systemic vascular resistance associated with observed changes in heart rate and blood pressure.

Condition or disease
Cardiac Output Sedation

Study Design
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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study to Assess the Ability of Non-invasive Bio-impedance Cardiac Monitoring to Detect and Trend Hemodynamic Variables During Dexmedetomidine (DEX) Sedation in Children for Radiology Procedures
Study Start Date : September 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011
Groups and Cohorts
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Group/Cohort
Children sedated by DEX
All pediatric patients (1 month to 18 years of age) eligible for Radiology Sedation Service for CT scan and Nuclear Medicine Scan procedure.


Outcome Measures
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Primary Outcome Measures :
  1. The primary aim is to ascertain if a decrease in heart rate (HR) with intravenous (IV) DEX is associated with a change in trend of cardiac output (CO) as measured by the ICON device. [ Time Frame: pre-, during, and post sedation ]

Secondary Outcome Measures :
  1. To determine the cardiac parameters provided by the ICON device during changes in blood pressure. [ Time Frame: pre-, during and post sedation ]

Eligibility Criteria
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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All pediatric patients (1 month to 18 years of age) eligible for Radiology Sedation Service for CT scan and Nuclear Medicine Scan procedure who agrees to participate in the study will have their vital signs and ICON measurements recorded continuously pre-sedation, during sedation and through recovery until discharge.
Criteria

Inclusion Criteria:

  • All pediatric patients (1 month to 18 years of age)
  • Eligible for Radiology Sedation Service for CT scan and Nuclear Medicine
  • Scan procedure

Exclusion Criteria:

  • Pacemakers and Vagus Nerve Stimulator
  • Mitral or Aorta Valve Dysfunction
  • Dextrocardia
  • Second or Third degree heart block
  • Current diagnosis of Cardiac, Pulmonary, Hepatic or Renal Failure
  • Current diagnosis of pulmonary masses/tumor/pleural effusions/pneumonia/edema
  • Pericardial effusion
  • Concomitant use of hypertension medications including ACE inhibitors, beta receptor and calcium channel blockers.
  • Large Implanted Metallic Devices (including orthodontic braces, spine rods, plates and screws)
  • Allergy to device electrodes
Contacts and Locations
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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): NCT01001533


Locations
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United States, Massachusetts
Children Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Jackson Wong, MD Children Hospital Boston
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jackson Wong, Assistant Professor of Pediatrics, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01001533    
Other Study ID Numbers: 09-03-0130
First Posted: October 26, 2009    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: June 2011
Keywords provided by Jackson Wong, Boston Children's Hospital:
Electrical Cardiometry
Dexmedetomidine
ICON
bio-impedance
cardiac monitor