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

Completed

• Conditions: Cardiac Output; Sedation

• Registration Number: NCT01001533
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Status Verified: 2011-06
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To determine the cardiac parameters provided by the ICON device during changes in blood pressure.	pre-, during and post sedation

Trial Locations

Locations (1)

Children Hospital Boston; 🇺🇸 Boston, Massachusetts, United States