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临床试验/NCT06174636
NCT06174636招募中不适用

Lung Overdistension and Abdominal Pressure Rise: an EIT Based Pilot Study

University of Padova2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
Variation of lung volume distribution

研究概览

简要总结

The goal of this pilot interventional no-profit study is to evaluate airway pressure, esophageal pressure and variations in lung volume distribution with EIT in mechanically ventilated patients admitted to our UTI with respiratory failure after the application of an abdominal weight and resulting increase of intra-abdominal pressure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Invasive mechanical ventilation in acute respiratory failure (PaO2/FiO2 <300 mmHg)
  • Need of PEEP trial
  • Need of urinary catheter (used to measure IAP)

排除标准

  • Contraindication to EIT use
  • Pacemaker or other metal device in thoracic region
  • Contraindication to abdominal weight placement
  • Surgical or traumatic incision on the abdomen
  • Severe abdominal hypertension
  • Esophageal diseases that counterindicate naso-gastric tube placement
  • Severe hemodynamic instability (norepinephrine > 0.1 mcg/kg/min; dobutamine or dopamine > 5 mcg/kg/min; epinephrine every dosage)
  • Severe obesity (BMI > 35 kg/m2)
  • Need of > 7 kg weight to reach 5 mmHg IAP increase

结局指标

主要结局

Variation of lung volume distribution

时间窗: through study completion, an average of 1 year

TID %

Variation of airway pressure

时间窗: through study completion, an average of 1 year

cmH2O

Variation of esophageal pressure

时间窗: through study completion, an average of 1 year

cmH2O

次要结局

未报告次要终点

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paolo Persona

Medical Doctor, Principal Investigator

University of Padova

研究点 (2)

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