This trial has been completed.

Conditions cardiac output, sedation
Sponsor Boston Children’s Hospital
Start date September 2009
End date September 2011
Trial size 17 participants
Trial identifier NCT01001533, 09-03-0130


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
All pediatric patients (1 month to 18 years of age) eligible for Radiology Sedation Service for CT scan and Nuclear Medicine Scan procedure.

Primary Outcomes

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

To determine the cardiac parameters provided by the ICON device during changes in blood pressure.
time frame: pre-, during and post sedation

Eligibility Criteria

Male or female participants from 1 month up to 18 years old.

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

Additional Information

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
Principal investigator Jackson Wong, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Boston Children’s Hospital.