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临床试验/NCT03868735
NCT03868735已完成不适用

Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2019年10月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
272
试验地点
1
主要终点
Length of Time on a Mechanical Ventilator

研究概览

简要总结

The primary aim of this study is to evaluate the CleanSweep™ Closed Suction System on time to first successful spontaneous breathing trial in mechanically ventilated patients in the medical intensive care unit. Secondary aims of this study are to evaluate the use endotracheal tube sweeping compared to closed suctioning effect on length of mechanical ventilation, length of ICU stay, length of total hospital stay, and occurrence of ventilator-associated events.

详细描述

This is designed as a prospective, randomized control trial, in a large, urban, academic medical center. This study will include mechanically ventilated patients (n = 272) in the medical intensive care unit (MICU) at Rush University Medical Center. It will exclude patients with a tracheostomy on admission, those requiring extracorporeal membrane oxygenation (ECMO), or transferred from an outside facility receiving more than 24 hours of mechanical ventilation. Two groups will be randomly assigned via computer randomization. The experimental group will be placed on the CleanSweep™ Closed Suction System immediately after intubation or upon arrival to the MICU. Endotracheal tubes (ETTs) will be cleaned with the balloon sweeping technology every time a respiratory therapist suctions the patient. The control group will be placed on the standard in-line suction device. Airway suctioning will be performed in both groups as per department policy (Catheter advanced until resistance is met and withdrawn slowly for a duration no longer than 15 seconds while applying negative pressure). Both groups will also receive a ventilator bundle that consists of head of bed elevation, ETT cuff pressure management, deep vein thrombosis prevention, daily sedation interruption and SBT, and oral care every 4 hours with chlorhexidine at 12pm (noon) and 12am midnight.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Orally intubated patient with endotracheal tube
  • •Mechanically ventilated less than 24 hours prior to enrollment

排除标准

  • •Less than 18 years old
  • •Tracheostomy tube
  • •Extracorporeal membrane oxygenation
  • •Transfer from outside hospital with more than 24 hours of mechanical ventilation

研究组 & 干预措施

CleanSweep Closed Suction System

Experimental

Device that includes balloon sweeping technology

干预措施: CleanSweep Closed Suction System (Device)

Standard in-line suction device

No Intervention

In-line suction device already in on intubated patients with an endotracheal tube

结局指标

主要结局

Length of Time on a Mechanical Ventilator

时间窗: Hospital admission to discharge (up to about 20 days)

Length of time on mechanical ventilation was recorded in hours.

次要结局

  • Length of Total Hospital Stay(Hospital admission to discharge (up to about 20 days))
  • Time to First Successful Spontaneous Breathing Trial (SBT)(Hospital admission to discharge (up to about 20 days))
  • Number of Participants With Ventilator-associated Events(Hospital admission to discharge (up to about 20 days))
  • Length of Time in the Intensive Care Unit(Hospital admission to discharge (up to about 20 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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