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临床试验/NCT01737190
NCT01737190Unknown不适用

PEEP Guided by Esophageal Balloon Measurement and Its Effect on Recruitment Maneuver

Wolfson Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
oxygenation

研究概览

简要总结

The aim of the study is to examine the effects of two different levels of PEEP on subsequent standard recruitment maneuver.

详细描述

In this study we will examine the effects of two levels of PEEP on subsequent recruitment maneuver. In the first group a recruitment maneuver will be performed in patients who are ventilated with PEEP level set according to the ARDS network algorithm.

Patients will then be crossed over to a study arm where another recruitment maneuver will be performed while PEEP is adjusted according to esophageal pressure measurements.

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

  • 20 Man and women older than 18 years will be recruited.
  • Patients with acute respiratory failure of any cause who are mechanically ventilated according to the ARDS network recommendations will be considered for inclusion to the study.
  • To be included in the study a prerequisite of high peak Inspiratory pressure (plateau pressure of 25 to 30 cmH2O) has to be present, and at least one of the following four severity inclusion criteria has to be met.
  • 1 - Low Total Respiratory system compliance (CT), defined as less than 50ml/cmH2O. 2 - PaO2 /FIO2 ratio of less than
  • 3 - Need for a PEEP greater than 10 cmH2O to maintain SaO2 of > 90%. 4 - PCO2 over 60 mmHg, or PH less than 7.2 that is attributed to respiratory acidosis.

排除标准

  • Patients with any of the following will be excluded from the study. Previous lung or chest wall surgery, previous esophageal surgery, known Achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoskoliosis.

结局指标

主要结局

oxygenation

时间窗: 4 hours

the primary end point in both groups will be oxygenation improvement after each intervention in each arm.

次要结局

  • lung compliance(4 hours)

研究者

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

Soroksky Arie

Dr.

Wolfson Medical Center

研究点 (2)

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