Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cardiac Output, Sedation

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children sedated by DEX<br>All pediatric patients (1 month to 18 years of age) eligible for Radiology Sedation Service for CT scan and Nuclear Medicine Scan procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | pre-, during, and post sedation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the cardiac parameters provided by the ICON device during changes in blood pressure. |  | pre-, during and post sedation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical Cardiometry, Dexmedetomidine, ICON, bio-impedance, cardiac monitor