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临床试验/NCT04996394
NCT04996394已完成不适用

Effects of Neuromuscular Blocking Agents on End Expiratory Lung Volume During Moderate-severe ARDS

University of Milano Bicocca1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年12月12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
15
试验地点
1
主要终点
End Expiratory Lung Volume

研究概览

简要总结

This is a monocentric, prospective, observational study that will be conducted in the general ICU of San Gerardo Hospital (Monza, Italy). Study protocol will be started when NMBAs infusion will be stopped for clinical reason until regain of spontaneous breathing activity.

Patients will be enrolled at the moment of NMBAs infusion interruption ("baseline" phase). Clinical data will be collected: hemodynamics, ventilation parameters and respiratory mechanics, arterial blood gas analysis, drugs used for sedation and their dosages. An EIT belt will be positioned around the patient's chest when clinical signs of spontaneous breathing activity will be detectable (unstable flow curve on the ventilator, deflection in airway pressure during an expiratory pause). In this phase ("NMBA interruption") same clinical data will be collected as at baseline. Patients will be ventilated in the same ventilation mode as before (Volume Controlled mechanical ventilation), but the inspiratory trigger on the ventilator will be turned on to reduce patient-ventilator asynchronies. When an EIT trace lasting at least 10 minutes will be recorded, an NMBA bolus (as prescribed by the treating physician) will be administered and a continuous infusion will be restarted. Clinical data will be collected again in this phase ("NMBA restart").

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

  • Patients with moderate-severe ARDS (according to Berlin definition)
  • Patients treated with NMBAs
  • age>18 years old

排除标准

  • pregnancy,
  • presence of air leaks (ex. presence of broncho-pleural fistula or pneumothorax)
  • presence of contraindications to EIT belt positioning ( ex. presence of pace-makers, presence of unstable spinal fractures).

结局指标

主要结局

End Expiratory Lung Volume

时间窗: Entire study duration (approx. 1 year)

Patients will be enrolled at the moment of NMBAs infusion interruption ("baseline" phase). An EIT belt will be positioned around the patient's chest when clinical signs of spontaneous breathing activity will be detectable (unstable flow curve on the ventilator, deflection in airway pressure during an expiratory pause). In this phase ("NMBA interruption") same clinical data will be collected as at baseline. When an EIT trace lasting at least 10 minutes will be recorded, an NMBA bolus (as prescribed by the treating physician) will be administered and a continuous infusion will be restarted. Clinical data will be collected again in this phase ("NMBA restart").

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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