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Completed

NCT Number: NCT01001533

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

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.

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Key information

Conditions

Cardiac Output Sedation

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Hospital Boston

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. To determine the cardiac parameters provided by the ICON device during changes in blood pressure.

    Time frame: pre-, during and post sedation

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study 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

Acronym: DEX-CO

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 26, 2009
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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