Does UROSHIELD® Influence Bacterial Growth On Endotracheal Tubes
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Number of days elapse until development of positive sputum culture
研究概览
简要总结
The purpose of this study is to examine the effect of UROSHIELD® (a device which generates low energy ultrasound waves) on development of bacterial colonies on endotracheal tubes, in patient receiving mechanical ventilation, and to determine whether this device lowers the rate of bacterial resistance to antibiotics.
详细描述
Ventilator Associated Pneumonia (VAP) is a common complication in patients treated by mechanical ventilation, supposedly related to development of bacterial colonization on the endotracheal tubes. Therefore many devices were designed to address this issue.
NanovibronixTM Company developed "UROSHIELD®" a device which generates low energy ultrasound wave in the nanometer range, and delivers these waves by an actuator which is connected externally to a urinary catheter. It was shown that using UROSHIELD®, there was reduction in development of bacterial colonies, and lower rate of resistance of bacteria to antibiotics.
Aim of the study:
To examine the effect of UROSHIELD® on development of bacterial colonies on endotracheal tubes, in patient receiving mechanical ventilation, and to determine whether this device lowers the rate of bacterial resistance to antibiotics.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Consecutive adult patients, with newly begun mechanical ventilation, will be connected to UROSHIELD® within 48 hours
排除标准
- •Pediatric patients
研究组 & 干预措施
UROSHIELD®
Randomly selected patients,(ratio 1:1) with newly begun mechanical ventilation, will be connected to a low energy acustic wave generator UROSHIELD® within 48 hours. Endotracheal secretions will be collected for culture and antibiotic sensitivity every 3 days for 15 consecutive days or until disconnection from the mechanical ventilation.
干预措施: UROSHIELD® (Device)
SHAM UROSHIELD®
same as abouve but with Sham device.
干预措施: SHAM UROSHIELD® (Device)
结局指标
主要结局
Number of days elapse until development of positive sputum culture
时间窗: 15-20 days
Sputum for culture will be obtained every 3 days. Number of days till sputum culture will convert from negative to positive one will be calculated and compared for the study and control groups.
次要结局
- Type of bacteria and antibiotic sensitivity(15-20 days)
研究者
REUVEN FRIEDMANN
head of geriatric ward
Shaare Zedek Medical Center