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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01001533

Acronym

DEX-CO

Enrollment

Registered

2009-10-26

Start date

2009-09-30

Completion date

2011-09-30

Last updated

2017-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output, Sedation

Keywords

Electrical Cardiometry, Dexmedetomidine, ICON, bio-impedance, cardiac monitor

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

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

Design outcomes

Primary

Measure	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

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

Countries

United States

Outcome results