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临床试验/NCT06729476
NCT06729476已完成不适用

The Effect of Uroshield on Sputum-specimen Bacterial Growth and Multidrug Resistant Organisms in Mechanically Ventilated Patients

Shaare Zedek Medical Center0 个研究点目标入组 48 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
主要终点
Sputum-specimen bacterial growth

研究概览

简要总结

The investigators retrospectively register the conduct of this study after its completion.

详细描述

Background: Ventilator-associated pneumonia is a frequent complication of mechanical ventilation, caused by bacterial proliferation and biofilm formation on endotracheal tubes. The UROSHIELDTM is a small device that generates low-energy surface acoustic waves, which transmit energy to the endotracheal tube through a thin cable attached to the tube. Laboratory studies using catheterized urinary tract models have shown a significant reduction in microbial colonization and reduced development of antimicrobial resistance in UROSHIELDTM device treated individuals.

Purpose: To evaluate the impact of a UROSHIELDTM device, adapted for endotracheal tube diameter, on the development of positive sputum cultures in intubated patients.

Methods: The study was prospective, double-blind, interventional and randomized. Included were newly intubated patients, who were randomized at a rate of 1:1 by a physician not involved in the study. Patients, treating staff and study investigators were blinded to whether the patients received true or sham devices. Sputum cultures were taken at baseline and every three days for 15 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Mechanically ventilated patients

排除标准

  • Less than 18 years of age, pregnant women

结局指标

主要结局

Sputum-specimen bacterial growth

时间窗: six months

Sputum specimen collection at day 0 and then every third day for 15 days.

Growth of multidrug resistant organisms from sputum cultures

时间窗: six months

Isolation of sputum specimens collected at day 0 and then every third day for 15 days.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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