NCT01547507Unknown不适用
Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System
Biovo Technologies Ltd1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2012年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- hemodynamic and respiratory data
研究概览
简要总结
The aim of this prospective, randomized study is to compare the performance, safety, and ease of use (usability) between two closed suction systems, the AirWay Medix Closed Suction System and Kimberly KimVent while intubated with an endotracheal in hospitals and ICU. 26 adults with an endotracheal tube and mechanical ventilation will be randomized into 2 groups to receive one of the following closed suction systems endotracheal tubes:
- AirWay Medix Closed Suction System
- KimVent Turbo-Cleaning Closed Suction System Kimberly clarK The groups will be compared regarding the safety, performance and ease of use (usability).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged greater than 18 years
- •Mechanically ventilated for more than 6 hours
- •Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment
- •Signed informed consent
- •Sexually active female subjects of childbearing potential must be practicing adequate contraception during the treatment period -
排除标准
- •Gross / massive hemoptysis
- •Received lung transplantation in the past
- •Admitted from other hospital already mechanically ventilated
- •Previously received mechanical ventilation
- •Active bronchial bleeding
- •Pregnant women, women who plan to become pregnant and breastfeeding women.
- •Substance or alcohol abuse
- •Participation in concurrent trials
- •Any reasons making the patient a poor candidate in the opinion of the investigator -
结局指标
主要结局
hemodynamic and respiratory data
时间窗: Patients will be followed until extubation
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
H-Guard Pilot Safety Evaluation in Haemodialysis PatientsRenal DiseaseRenal FailureRenal InsufficiencyNCT06070337Invizius Limited8
已完成
不适用
Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk PatientsRectal CancerColon CancerNCT00867724GI View Ltd.68
Unknown
不适用
Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated NoseDry NoseNose IrritationNCT05499078Church & Dwight Company, Inc.40
撤回
3 期
Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous EmphysemaChronic Obstructive Pulmonary Disease (COPD)EmphysemaNCT01908933Aeris Therapeutics
已完成
1 期
A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) DeviceAortic Valve StenosisNCT01721642Apica Cardiovascular Limited31