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临床试验/NCT04739007
NCT04739007撤回不适用

Pulmonary Physiologic Assessment of Patients on Veno-arterial Extracorporeal Membrane Oxygenation (VA ECMO)

Massachusetts General Hospital1 个研究点 分布在 1 个国家开始时间: 2021年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Percent of total distribution of ventilation by region, on given ventilator settings

研究概览

简要总结

There is limited data on the respiratory system mechanics and ideal mode of ventilation for patients on veno-arterial extra-corporeal membrane oxygenation (VA ECMO) post cardiac arrest. In this observational study, the investigators will review and/or obtain laboratory, hemodynamic, respiratory system mechanical, and clinical data from patients on VA ECMO. The specific aims of this study are as follows:

Aim 1: To characterize the lung ventilation strategy employed in patients on VA ECMO and its success.

Aim 2: To characterize respiratory system mechanics while on ECMO using esophageal manometry and Electrical Impedance Tomography (EIT).

Aim 3: To characterize right heart function and pulmonary vascular hemodynamics on the employed ventilation strategy.

The overarching hypothesis is that fine-tuned individualized ventilation might be superior to an algorithm that does not account for cardiac and pulmonary functions. Therefore, the aims of this study are to identify areas in which the ventilation strategy may theoretically be suboptimal, which will guide future interventional studies investigating alternatives methods of ventilation which may reduce time on the ventilator after cardiac arrest, time in the intensive care unit, and need for veno-venous ECMO.

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

  • On VA ECMO after cardiac arrest
  • Between 18 and 85 years of age
  • Has an orogastric or nasogastric tube with esophageal balloon capabilities in place

排除标准

  • Known pre-existing significant pulmonary pathology
  • Pacemaker or implanted cardiac defibrillator

结局指标

主要结局

Percent of total distribution of ventilation by region, on given ventilator settings

时间窗: Within 24-48 hours of ECMO cannulation

EIT will be used to determine the percent of total ventilation occurring in each of four lung quadrants on an axial plane: right upper, left upper, right lower, and left lower.

次要结局

  • Time on VA-ECMO(14 days, 90 days)
  • 90-day mortality(90 days)
  • Time on mechanical ventilation(14 days, 90 days)
  • Need to transition to VV-ECMO(14 days, 90 days)
  • Time in ICU(14 days, 90 days)
  • Incidence of ventilator-associated pneumonia(14 days, 90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lorenzo Berra, MD

Reginald Jenney Associate Professor of Anaesthesia

Massachusetts General Hospital

研究点 (1)

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