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临床试验/NCT04180410
NCT04180410Unknown不适用

Monitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation

BioSerenity2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
BioSerenity
入组人数
60
试验地点
2
主要终点
acute respiratory failure

研究概览

简要总结

The Electrical Impedance Tomography (EIT) is a non-invasive exam. This exam performed on the lung continuously produces cross-sectional images of lung function. It may be relevant in lung description.

详细描述

The aim is to follow the patients after extubation for the lung description.

EIT exam is performed before extubation, during follow-up visits and 48H after extubation

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age> 65 years
  • Invasive mechanical ventilation time greater than 48 hours
  • known or suspected Chronic obstructive pulmonary disease
  • Known or suspected heart failure
  • Success in the spontaneous ventilation and extubation test scheduled by the doctor in charge
  • Patient or trusted person who has been informed of the study and has consented to participate

排除标准

  • Pregnant women, minor patients
  • Patients under extracorporeal circulatory assistance (ECMO)
  • Refusal of the patient
  • Contraindications to the realization of the phrenic nerve stimulation technique:
  • Pacemaker, implantable cardiac defibrillator and other pacemakers
  • Spinal implants, thoracic drains ...
  • Copper allergy
  • Epileptic patients
  • Patients performing uncontrolled body movements
  • Contraindications to the realization of the technique of Electrical Imaging Tomography:
  • Breast circumference not between 70 cm and 150 cm.
  • Body mass index (BMI) greater than 50
  • Impossibility of placing the CT belt at the level of the chest skin (lesions, bandages, dressings, chest drains ...)
  • Patients with unstable spinal lesions or fractures
  • Allergy to tomography belt materials: silicone, brass, stainless steel
  • Pacemaker, implantable cardiac defibrillator and other pacemakers
  • Patients under legal protection (tutorship / guardianship)

结局指标

主要结局

acute respiratory failure

时间窗: 48 hours

Occurrence of extubation failure

次要结局

  • pulmonary ventilation(48 hours)

研究者

发起方
BioSerenity
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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