跳至主要内容
临床试验/NCT03486002
NCT03486002终止不适用

EFFECTS OF TELEFLEX CATHETER (CLEANSWEEP) ON VENTILATOR MECHANICS

Duke University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
2
主要终点
Change in endotracheal tube resistance during mechanical ventilation after 4 suction procedures

研究概览

简要总结

This study is designed to compare the effectiveness of a closed suction system with an inflatable balloon on the catheter (Cleansweep system) to that of a standard closed suction system in terms of reducing the interior resistance of endotracheal tubes. Subjects who require frequent suctioning ( > every 2.5 hours) and who have stable cardiovascular systems will be randomized to receive suctioning either through the Cleansweep system or standard system initially followed by the corresponding system. The subjects will be suctioned every two hours for eight hours ( the first 2 suction procedures with one system followed by 2 with the other system). After each suction procedure measurements of resistance will be made using peak and plateau pressures.

Analysis: For each patient, data for both procedures on each catheter system will be pooled and mean differences between the standard system and the Cleansweep system will be calculated. For all 20 patients the mean (+/- SD) of these differences will be calculated and significance will be sought using appropriate statistical tests. The study will be unblinded and randomization determines merely which system will used initially for the first 2 procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
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

入选标准

  • Intubated, mechanically ventilated patients who require suctioning more often than every 2.5 hours

排除标准

  • Unstable cardiovascular system (significant arrythmias, blood pressure support requiring > 2 pressors
  • refractory hypoxemia (P/F ratio < 80)

结局指标

主要结局

Change in endotracheal tube resistance during mechanical ventilation after 4 suction procedures

时间窗: 8 hours

Measurements of resistance will be made following each suction procedure (2 with the Cleansweep system and 2 with the standard system)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验