Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation
Completed
Conditions studied: Cardiac Output, Sedation
In brief
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.
Key facts
- Study ID
- NCT01001533
- Run by
- Boston Children's Hospital
- People needed
- 17
- Starts
- 2009-09-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2017-01-05
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Children Hospital Boston — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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