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

NCT01001533 | Completed

• 1 other identifier: 09-03-0130
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Output; Sedation

Keywords

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

Outcome Measures

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.

  pre-, during, and post sedation

Secondary Outcomes (1)

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

  pre-, during and post sedation

Study Arms (1)

Children sedated by DEX

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

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All pediatric patients (1 month to 18 years of age) eligible for Radiology Sedation Service for CT scan and Nuclear Medicine Scan procedure who agrees to participate in the study will have their vital signs and ICON measurements recorded continuously pre-sedation, during sedation and through recovery until discharge.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Wong J, Steil GM, Curtis M, Papas A, Zurakowski D, Mason KP. Cardiovascular effects of dexmedetomidine sedation in children. Anesth Analg. 2012 Jan;114(1):193-9. doi: 10.1213/ANE.0b013e3182326d5a. Epub 2011 Sep 29.

  PMID: 21965374 DERIVED

Study Officials

• Jackson Wong, MD

  Children Hospital Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 26, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 5, 2017

Record last verified: 2011-06

Locations

US (1)