Clinical trial NCT01001533: Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output
Sedation
Keywords: Electrical Cardiometry
Dexmedetomidine
ICON
bio-impedance
cardiac monitor
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2009-10-26
Enrollment: 17
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: pre-, during, and post sedation
Secondary outcomes:
measure: To determine the cardiac parameters provided by the ICON device during changes in blood pressure.
timeFrame: pre-, during and post sedation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children Hospital Boston
state: Massachusetts
Study officials:
affiliation: Children Hospital Boston
name: Jackson Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.