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临床试验/NCT06321497
NCT06321497招募中不适用

Measuring the Impact of Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury in Mechanically Ventilated Patients

Peninsula Health1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
Reduction in driving airway pressures

研究概览

简要总结

Lung protective ventilation with low tidal volumes and low driving pressure are known to reduce mortality in mechanically ventilated patients with acute respiratory failure. This reduction in mortality is known be due to reduction of ventilator induced lung injury that occurs due to high tidal volumes and high driving pressure. When receiving such mechanical ventilation, some patients develop hypercapnia and associated hypercapnic acidosis. Such patients have an increased risk of mortality. While the exact reasons for such increase in mortality is not known, it is recommended to minimise hypercapnia and hypercapnic acidosis during lung protective ventilation. Minimally invasive extracorporeal carbon dioxide removal (ECCO2R) devices are shown to reduce hypercapnia and hypercapnic acidosis. There are several devices that are currently available in the current clinical practice. However, the effect of these devices on reduction in ventilator induced lung injury is not clearly demonstrated. This study aims to assess the use of an ECCO2R device called Prismalung in reducing ventilator induced lung injury. PrismaLung is currently used in our intensive care unit. This assessment is done by measuring interleukins in bronchoalveolar lavage fluid and blood interleukin levels as well as clinical assessment including the reduction of driving pressure.

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

  • Adult patients (18 years or older) with diagnosis of ARDS as per Berlin Definition
  • Driving pressure (ΔP) > 14 and/or Plateau >/= 25 (ΔP is calculated using as plateau pressure minus positive end-expiratory pressure)20 Respiratory rate > 20 breaths per minute pH < 7.25 and PaCO2 >45

排除标准

  • ARDS lasting more than 72 hours at the time of inclusion High pressure (Plateau pressure >30 cm H2O) or high FiO2 (>0·8) ventilation for more than 168 h (7 days); Life threatening hemodynamic instability as defined by ongoing arrhythmias that is not responsive to treatment Contraindication to limited anticoagulation Treatment limitation including not for resuscitation and not for reintubation Patients with potentially irreversible respiratory failure caused by conditions such as pulmonary fibrosis.

结局指标

主要结局

Reduction in driving airway pressures

时间窗: 72 and 144 hours post initiation of ECCO2R

次要结局

  • Reduction in pulmonary inflammation assessed by interleukins in lung(72 and 144 hours post initiation of ECCO2R)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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