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临床试验/NCT02945917
NCT02945917Unknown不适用

Positive End-expiratory Pressure and Esophageal Catheter Optimal Calibration Volume in ARDS Patients

Magni Federico1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
16
试验地点
1
主要终点
transpulmonary pressure measured estimating pleural pressure through the esophageal balloon

研究概览

简要总结

The use of esophageal balloon catheter to estimate pleural pressure has gained renewed popularity in recent years. Indeed, measurement of transpulmonary pressure may allow a more pathophysiological-based approach to ventilator strategy in acute respiratory distress syndrome (ARDS) patients. Nevertheless, it is well known that esophageal balloon catheter derived parameters can be influenced by several patient-related or technical-related factors.

During a PEEP trial, the investigators will observe in-vivo the esophageal pressure and derived measurements obtained using different esophageal balloon calibration volumes.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of ARDS with a PEEP of at least 8 cmH2O
  • Fraction of inspired oxygen not higher than 80%
  • Intubated and ventilated in Volume Control Ventilation mode set by the attending physician according to clinical criteria
  • Need of continuous sedation through intravenous anesthetics and full neuromuscular blockade

排除标准

  • Been pregnant or breastfeeding
  • Hemodynamic instability
  • Presence of tracheobronchial fistula
  • Known pneumothorax
  • Leak in airway circuitry
  • Presence of any kind of inhalator therapy (e.g. Heliox, nitric oxide, anesthetic conserving device)
  • Recent history of nasal trauma or lesion of nasal cavity
  • Recent history of esophageal, gastrointestinal, ENT, thoracic or cardiac surgery (less than 2 months)
  • Known or suspected esophageal varices
  • Congenital, acquired or drug-induced hemostatic disorder
  • Thrombocytopenia (less than 50000/mm3)
  • Recent history of Traumatic Brain Injury or thoraco-abdominal trauma (less than 1 months)
  • Rib or sternal fractures

结局指标

主要结局

transpulmonary pressure measured estimating pleural pressure through the esophageal balloon

时间窗: within 10 minutes after esophageal balloon volume changing

次要结局

  • End-expiratory lung volume(within 60 minutes after PEEP changing)

研究者

发起方
Magni Federico
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Magni Federico

UOC Anestesia e Rianimazione ASST Monza

San Gerardo Hospital

研究点 (1)

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