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

Sedation Clinical Trial

— DEX-CO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001533
• Other study ID #: 09-03-0130
• Status: Completed
• Phase: N/A
• First received: October 23, 2009
• Last updated: January 4, 2017
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: June 2011
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Output
• Sedation

Locations

Country	Name	City	State
United States	Children Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine the cardiac parameters provided by the ICON device during changes in blood pressure.		pre-, during and post sedation	No