Randomized Controlled Trial of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Venilator Associated Events (VAE)
研究概览
简要总结
Aerosol delivery during mechanical ventilation has long been a long debated topic. As evidence-based knowledge about the delivery of aerosol to the lungs of mechanically ventilated patients increases, one piece of the puzzle has remained unexplored; measurement of clinically relevant outcomes. The primary aim of this research is to compare clinical outcomes (ventilator-associated events (VAEs), length of stay (LOS) in intensive care unit (ICU), and total days on mechanical ventilation) when using a traditional jet nebulizer versus a newer generation vibrating mesh nebulizer during mechanical ventilation. The secondary aim of this research is to identify source of bacteria by obtaining cultures of each nebulizer and ventilator circuit and plating them for colony growth and identification.
详细描述
This pilot study was designed as a randomized, controlled trial comparing clinical outcomes and contamination rates in jet nebulizers versus vibrating mesh nebulizers. The sample size will be one of consecutive convenience over an entire year (September 2013-September 2014) to include all seasons. The study will be performed at Rush University Medical Center (RUMC) in Chicago, IL.
Each mechanically ventilated patient within inclusion criteria, with a physician order for aerosol treatment, will be randomized to either the jet nebulizer or mesh nebulizer group using SPSS computer software. The respiratory care staff will place the nebulization device in the ventilator circuit per hospital protocol. Both devices, jet and mesh nebulizers, are currently standard practice; therefore hospital protocol will be followed regarding placement and administration of ordered aerosol treatment.
The study subject will remain on the device to which they were randomized for the duration of their hospital stay to obtain clinical outcome data. Study staff to be notified of patient extubation from mechanical ventilation, discharge from intensive care unit, or expiration; this will conclude participant involvement in the study. Retrospective clinical outcome data will be obtained from the subject's electronic medical chart at conclusion of study.
Retrospective data to include:
- LOS in ICU (days)
- LOS on mechanical ventilator (days)
- Drug administration information
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 1 y/o
- •Intubated with endotracheal tube (ETT) and on mechanical ventilation
- •Patient in all intensive care units at Rush University Medical Center
- •Physician order for aerosolized breathing treatment in medical record
排除标准
- •Age < 1 y/o
- •Diaphragmatic paralysis
- •Paraplegic or high spinal cord injury
- •Brain death
结局指标
主要结局
Venilator Associated Events (VAE)
时间窗: duration of mechanical ventilation or discharge from the intensive care unit
Ventilator associated conditions (VAC) and infection related ventilator associated conditions (IVAC) were identified based on the 2013 NHSN Surveillance for VAEs (e,g., "See page 92 at https://www.cdc.gov/nhsn/PDFs/pscManual/validation/2013-PSC-Manual-validate.pdf for detailed criteria.")
次要结局
- Length of Stay in Intensive Care Unit(discharge from the intensive care unit)
- Days on Mechanical Ventilation(discharge from the intensive care unit)
- Participants With Bacterial Growth(duration of mechanical ventilation or discharge from the intensive care unit)