跳至主要内容
临床试验/NCT00891085
NCT00891085终止不适用

Synchronized Intermittent Mechanical Ventilation vs Open Lung Ventilation With Spontaneous Respiration

University of New Mexico1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
1
主要终点
Reduction in ventilator days

研究概览

简要总结

The purpose of this study is to collect data on patients who are on breathing machines (ventilators) in the Trauma Surgical Intensive Care Unit (TSICU). This data may help us to determine if one form of assisted breathing is better than another. The two forms of assisted breathing being compared in this study are called BiVent and SIMV. (7) BiVent and SIMV are both delivered by a ventilator but differ in how they assist breathing. SIMV is an older form of mechanical breathing that blows air into the lungs to inflate the lungs. BiVent is a newer form of mechanical ventilation that permits the patient to pull air into the lungs as we normally do. Both BiVent and SIMV are currently being used on a regular basis in the TSICU. The investigators hope that this study will determine if one method of assisted breathing is better than another in preventing complications associated with mechanically assisted breathing.

详细描述

SOLV Hypothesis:

A prospective, randomized trial directly comparing open lung ventilation (OLV) with spontaneous breathing (SB) utilizing BiVent on the Maquet Servo-I versus synchronized intermittent mechanical ventilation (SIMV) will be conducted in the trauma-surgical intensive care unit at the University Hospital (TSICU). Both OLV-SB and SIMV protocols have been designed according to lung protective strategies. The primary goal of the SOLV trial is to see determine if the early application of open lung ventilation will less ventilator days. In addition, several secondary endpoints will be evaluated. It is not anticipated that this study will be powered to show a mortality difference.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • >/=18 years of age, ISS >/=25, on ventilator for more than 48 hours

排除标准

  • less than 18 years of age, die or come off ventilator in less than 48 hours

结局指标

主要结局

Reduction in ventilator days

时间窗: 4 years

次要结局

  • Progression to acute lung injury/acute respiratory distress syndrome (ALI/ARDS)(4 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Marinaro

professor

University of New Mexico

研究点 (1)

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