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临床试验/NCT01272882
NCT01272882已完成不适用

Electrical Impedance Tomography (EIT) Monitoring: A Pilot Comparison to Standard of Care Assessments in Adults With Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS)

Christiana Care Health Services1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2010年5月1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
13
试验地点
1
主要终点
Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients

研究概览

简要总结

Electrical impedance tomography (EIT) monitoring has been researched as a method to determine the spatial impedance distribution in a body cross section, but has yet to become an established clinical tool. EIT monitoring gives a dynamic, breath-to-breath measurement of both global and regional ventilation. Recently, there has been evidence that EIT monitoring has great potential to become a non-invasive bedside tool for assessment of regional lung ventilation without documented hazards. Potential applications include any adult patients in acute respiratory failure. Data collected from this research may contribute to improved patient safety outcomes.

PURPOSE:

The purpose of this pilot study is to examine the feasibility of using the EIT monitor in intensive care unit (ICU) setting on patients with acute respiratory failure and to compare the EIT monitor data to standard of care patient assessments. It is hypothesized that the EIT monitor, when applied to adults in acute respiratory failure, will correlate with conventional standard of care assessments for these patients.

详细描述

INTRODUCTION:

Electrical impedance tomography (EIT) monitoring has been researched as a method to determine the spatial impedance distribution in a body cross section, but has yet to become an established clinical tool. EIT monitoring gives a dynamic, breath-to-breath measurement of both global and regional ventilation. Recently, there has been evidence that EIT monitoring has great potential to become a non-invasive bedside tool for assessment of regional lung ventilation without documented hazards. Potential applications include any adult patients in acute respiratory failure. Data collected from this research may contribute to improved patient safety outcomes.

PURPOSE:

The purpose of this pilot study is to examine the feasibility of using the EIT monitor in ICU setting on patients with acute respiratory failure and to compare the EIT monitor data to standard of care patient assessments. It is hypothesized that the EIT monitor, when applied to adults in acute respiratory failure, will correlate with conventional standard of care assessments for these patients.

METHOD:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • •Patients will be included in this study if the following criteria have been met:
  • •Males and females > 18 years old (non-pregnant, non-lactating females).
  • •Partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ratio < 300 torr.
  • •Signed informed consent has been obtained.

排除标准

  • •Females who are pregnant or lactating.
  • •Patients with skin abrasions or wounds in the chest area.
  • •Patients receiving dialysis.
  • •Patients with pacemakers or paced EKG rhythms.

研究组 & 干预措施

Adults with ARDS or ALI

Experimental

Adults with PaO2/FiO2 ratio less than 300. Consented patients will be placed on EIT monitor. The only intervention is the addition of Electrical Impedance Tomography monitoring using the Chest belt with 16 electrodes connected to the EIT device. No changes to standard patient care will occur other than collecting EIT monitor data.

干预措施: Electrical Impedance Tomography monitoring (Device)

结局指标

主要结局

Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients

时间窗: At the start of monitoring once the patient was consented and enrolled.

Feasibility for the purposes of our study was the ability to apply the device to a diverse population of ARDS/ALI patients and obtain EIT data from the device.

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 (1)

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