NCT00137319终止不适用
An Evaluation of an Impedance Threshold Device (ITD) to Improve Hemodynamic Function During Orthostatic Challenge in Burn Patients
United States Army Institute of Surgical Research2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2004年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.
研究概览
简要总结
This study will see if a special piece of equipment can help burn patients who have been in bed for a long time to get out of bed without feeling dizzy or faint.
详细描述
To measure stroke volume, cardiac output, arterial blood pressure and cerebral blood flow velocity in human patients while they undergo exposure to head-up tilt that is designed to test their tolerance to an orthostatic challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Military or civilian males or females between the ages of 18-65 years
- •Burn injury with at least one unburned finger for Portapres measurement
- •Minimum of 96 hours bedrest or physician directive to tilt
排除标准
- •Age < 18 and > 65 years
- •Facial burns when application of ITD device would cause further trauma
- •Medical monitoring devices that preclude the use of the ITD
- •Signs of cardiac abnormalities, autonomic dysfunction
- •Chronic obstructive pulmonary disease (COPD), or any other respiratory limitations (ventilator dependent, intubated, tracheostomy) limiting use of ITD
- •History of pre-syncopal/syncopal episodes or orthostatic hypotension
- •History of atherosclerotic coronary heart disease
- •Patients taking any kind of cardiovascular pressor medications
- •Inability to obtain a Portapres pulse wave validated by blood pressure cuff with +/- 5mmHg diastolic blood pressure
- •Unable to provide informed consent for self
结局指标
主要结局
Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.
时间窗: 1 hour
次要结局
未报告次要终点
研究者
研究点 (2)
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