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临床试验/NCT02930174
NCT02930174已完成不适用

EIT Assessment of Lung Volume and Tidal Distribution: A Comparison of Non-Invasive Ventilation Devices

University of Michigan2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Global Tidal Variation (TID)

研究概览

简要总结

This study is being done to further the investigators' knowledge of the EIT system and to see if measures between two non-invasive ventilation systems routinely used clinically are equivalent.

详细描述

Mechanical ventilation is life-saving technology but it can also inadvertently induce lung injury and increase morbidity and mortality. There currently is not an easy method of assessing the impact ventilator settings have on the degree of lung inflation. Computed tomography (CT), the gold standard for visually monitoring lung function, can provide detailed regional information of the lung. Unfortunately, it necessitates moving critically ill patients to a special diagnostic room and involves exposure to radiation like an X-ray.

A technique introduced in the 1980's, electrical impedance tomography (EIT), can non-invasively provide similar monitoring of lung function, and without the exposure to radiation. This imaging technique applies small alternating currents of electricity to surface electrodes to construct cross-sectional images of the lung.

Over that past several decades EIT has moved from the research lab to commercially available devices that are used at the bedside. EIT has also been applied to study the effects of various devices used to provide non-invasive ventilation. EIT may prove useful to optimally adjust non-invasive ventilation settings to improve ventilation and oxygenation. One such EIT system is manufactured by Draeger Medical. It is available in Europe and Canada but is not yet FDA approved for use in the United States.

This study is being done with healthy volunteers to further the investigators' knowledge of the EIT system and to see if measures between two non-invasive ventilation systems routinely used clinically are equivalent.

As this is a preliminary study looking at the EIT system vs 2 other devices, outcomes measures may be modified as the study progresses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
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

  • Age 18 years or older

排除标准

  • Use of a cardiac pacemaker, an implantable cardioverter-defibrillator (ICD) or any other active implants

结局指标

主要结局

Global Tidal Variation (TID)

时间窗: 1 day

TID is the distribution of ventilation for a breath averaged over a defined section, the entire lung. TID is analogous to the tidal volume. Baseline is defined to be 100% and other measures are in comparison to baseline (eg, a value of 102 represents a 2% increase from baseline).

次要结局

  • Regional Tidal Variation: Ventral(1 day)
  • Global Change in End-expiratory Lung Impedance (EELI)(1 day)
  • Regional Change in EELI: Dorsal(1 day)
  • Regional Tidal Variation: Dorsal(1 day)
  • Regional Change in EELI: Ventral(1 day)

研究者

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

Carl Haas

Education & Research Coordinator, Respiratory Care

University of Michigan

研究点 (2)

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