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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pediatric patients (1 month to 18 years of age)
- •Eligible for Radiology Sedation Service for CT scan and Nuclear Medicine
- •Scan procedure
排除标准
- •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
结局指标
主要结局
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.
时间窗: pre-, during, and post sedation
次要结局
- To determine the cardiac parameters provided by the ICON device during changes in blood pressure.(pre-, during and post sedation)
研究者
Jackson Wong
Assistant Professor of Pediatrics
Boston Children's Hospital