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临床试验/NCT06408272
NCT06408272尚未招募不适用

Electrical Impedance Tomography (EIT) for the Setting of High-pressure in Patients With Acute Respiratory Distress Syndrome (ARDS) on Time Controlled Adaptive Ventilation (TCAV).

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
12
试验地点
1
主要终点
Percentage of collapsed units on EIT

研究概览

简要总结

Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure. The therapeutic management is currently based on the treatment of the cause of ARDS, and on mechanical ventilation with positive expiratory pressure (PEEP). Another strategy that could be used is Time Controlled Adaptive Ventilation (TCAV) method based on ventilation using the airway pressure release ventilation (APRV) mode.

Electrical impedance tomography (EIT) allows individual, non-invasive, real-time, bedside, radiation-free imaging of an anteroposterior section of the right and left lungs, with global and regional dynamic analyses.

The aim of the study is to evaluate EIT for PHigh titration of TCAV.

详细描述

Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure with a mortality rate of up to 35% for the most severe forms. The therapeutic management is currently based on the treatment of the cause of ARDS, and on mechanical ventilation with positive expiratory pressure (PEEP). Another strategy that could be used is Time Controlled Adaptive Ventilation (TCAV) method based on ventilation using the airway pressure release ventilation (APRV) mode.

The TCAV method is based on a prolonged THigh set at a constant pressure, creating a continuous positive pressure phase associated with a brief release during a TLow allowing the elimination of carbon dioxide and the creation of an intrinsic PEEP. With long high pressure phase this method could result in better recruitment but could also expose the patient to overdistention. While the TLow setting is well defined, level of PHigh is not standardized.

Electrical impedance tomography (EIT) allows individual, non-invasive, real-time, bedside, radiation-free imaging of an anteroposterior section of the right and left lungs, with global and regional dynamic analyses. Results of recent studies have highlighted the benefits of EIT, especially for ARDS patients in titrating PEEP in volume-controlled ventilation.

To date, no published study has evaluated EIT for PHigh titration using the TCAV method in patients with severe ARDS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate to severe ARDS patients with more than 24 hours of mechanical ventilation
  • Under sedation with a Richmond Rating Scale less than or equal to -2.

排除标准

  • Patients with a pacemaker or automatic implantable defibrillator
  • Pregnant women.
  • Contraindications to chest belt placement (e.g., spinal or thoracic recent surgery)
  • Undrained pneumothorax, broncho-pleural fistula
  • Hemodynamic instability (i.e., use of vasopressors at > 2 ug.kg.min of norepinephrine)
  • Patients on mechanical ventilation during more than 7 days

结局指标

主要结局

Percentage of collapsed units on EIT

时间窗: through study completion an average of 1 day

Percentage of collapsed lung areas measured at increasing levels of Phigh

次要结局

  • Percentage of overdistanded units(through study completion an average of 1 day)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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