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

Boston Children's Hospital

Status: Completed

Conditions: Cardiac Output; Sedation

Study type: Observational

Funder types: Other

Identifiers

NCT01001533

09-03-0130

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

17 participants in 1 patient group

Children sedated by DEX

Description:

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