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临床试验/NCT04235231
NCT04235231已完成不适用

The Effect of Lateral Tilt on Ventilation Distribution in Lungs Assessed by Electrical Impedance Tomography: A Pilot Prospective Randomized Study in Neurocritical Care

Regional Hospital Liberec2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
试验地点
2
主要终点
Atelectasis/collapse

研究概览

简要总结

Prevention of lung inhomogeneity is an essential part of preventive strategy in neurocritical care, reducing the risks of secondary brain damage from hypoxemia, hypo/hypercapnia or pneumonia.

详细描述

In the monocentric, intervention, prospective, randomized study, the investigators will examine the effect of lateral tilting (routinely used in critical care) on the lung inhomogeneity that will be analyzed by electrical impedance tomography (EIT) in the unconscious patients with acute primary brain disease and artificial pulmonary ventilation. Two types of lateral tilting will be compared: manual positioning of body by nurse versus the bed tilting (15° lateral tilt, original company (LINET) and product brand name (Eleganza 5).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

Research Randomizer

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary brain disease
  • Hospitalization in Neurocenter, Neurointensive Care Unit
  • Age>18 years
  • Unconsciousness
  • Artificial pulmonary ventilation

排除标准

  • Intracranial hypertension
  • History of primary lung disease
  • The terminal stage of the disease
  • Refractory hemodynamic instability

结局指标

主要结局

Atelectasis/collapse

时间窗: up to 24 weeks

Assessed by electrical impedance tomography (EIT) or chest x-ray (CXR) at end of observation period

次要结局

  • Evaluating hemodynamic parameters(up to 24 weeks)
  • Comparing duration of stay in Neurocenter Neurointensive Care Unit(up to 24 weeks)
  • Profiling pneumonia incidence(up to 24 weeks)
  • Evaluating oxygenation parameters(up to 24 weeks)
  • Cost effectiveness measurement between two groups(up to 24 weeks)

研究者

发起方
Regional Hospital Liberec
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vera Spatenkova, MD, Ph.D.

Head of Neurocenter

Regional Hospital Liberec

研究点 (2)

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