The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients, a Feasibility Study. (the Soundprobe Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR
研究概览
简要总结
Study to assess the feasibility of an external ultrasound fixator (ProbeFix)
详细描述
Rationale: Study to assess the feasibility of an external ultrasound fixator (ProbeFix) Objective: Cardiac output measurements using transthoracic ultrasound (TTE) with and without the use of the probeFixR will be evaluated in terms of accuracy. The TTE measurements will be combined with another form of cardiac output measurements (FlotracR) after a passive leg rasing (PLR) test.
Study design prospective, feasibility study Study population: Adult Intensive Care patients ( > 18 years)
Intervention (if applicable):
Consecutive adult patients on the ICU in which the FlotracR monitor is used will be evaluated after detection of hypovolemia.
Main study parameters/endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Intensive Care patients ( > 18 years), with hypovolemia detected with Flotrac (SVV > 10%)
排除标准
- •Pregnancy
- •Atrial fibrillation or other irregular heart rhythm
- •Pulmonary edema
- •PLR not possible (eg neurological disease, spinal trauma, restricted limb movement, deep venous thrombosis, or any other reason as indicated by the attending intensivist).
- •age < 18 years
研究组 & 干预措施
Cardiac output measurements
Cardiac output will be measured using TTE with and without the use of Probefix so not 2 arms but 2 consecutive measurements in the same patient
干预措施: Probefix (Device)
结局指标
主要结局
The correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR
时间窗: 8 weeks
A Bland and Altman plot will be constructed and the limits of agreement will be calculated.
次要结局
- Patients in which the ProbeFixR can be used(8 weeks)
- Skin marks as possible side effect; scored as 'no skin marks', 'mild skin marks (no treatment necessary)' or 'severe skin marks (surgical or medical treatment necessary)'(8 weeks)
- Is the Probefix unpleasant on a scale of 0-10(8 weeks)