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临床试验/NCT00260676
NCT00260676Unknown3 期

a Randomised Control Trial on Protective Ventilatory Strategy in Potential Organ Donors

University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2004年9月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
200
试验地点
2
主要终点
To increase the number of lungs that meet the eligibility criteria for transplantation

研究概览

简要总结

The aim of the study is to verify if a "PROTECTIVE" ventilatory strategy (low tidal volume and high PEEP, application of CPAP during the apnea test and recruitment maneuvers), improves lung function and increases the number of lungs eligible for transplantation.

详细描述

Lung transplantation reduces mortality in patients with severe pulmonary diseases. While 50-70% of kidney, liver and heart are eligible for transplantation, only 20% of the lungs fit the criteria for transplant. More than 30% of the lungs theoretically suitable for donation are not actually collected because following brain death they develop severe hypoxemia and abnormal chest X-ray. Guidelines for critical care management of potential organ donors suggest that after the diagnosis of brain death, treatment priority can be shifted from cerebral protection to a strategy aimed at preserving solid organ perfusion and function. However the ventilatory strategy recommended for potential lung donors is similar to the one proposed for brain injured patients. This ventilatory strategy based on high Vt and low PEEP may induce a further exacerbation of the pulmonary and systemic inflammatory response in patients with acute lung injury/acute respiratory distress syndrome. Moreover, recent data suggest that this strategy may be harmful in "normal lungs" of mechanical ventilated patients. Aim of the study is to verify if a "PROTECTIVE" ventilatory strategy (low tidal volume and high PEEP, application of CPAP during the apnea test and recruitment maneuvers) improves lung function. Primary end point of the study is to increase the number of lungs that meet the eligibility criteria for transplantation. Secondary end point is to increase the number of lungs really transplanted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-65 years
  • Chest X-ray: no infiltrates
  • Duration of mechanical ventilation from the admission to ICU to the clinical diagnosis of brain death < 5 days
  • No history of Smoking (1 pack/day for 20 years; 1/2 pack/day for 40 years; 2 packs/day for 10 years)
  • No history of Asthma
  • No history of COPD
  • No history of Trauma
  • No history of Thoracic surgery

排除标准

  • Evidence of aspiration (chest X-ray or bronchoscopy) or sepsis
  • Purulent secretions (tracheal suction or bronchoscopy)
  • Sputum Gram stain with bacteria, fungus, significant number of WBC

结局指标

主要结局

To increase the number of lungs that meet the eligibility criteria for transplantation

时间窗: end of brain death diagnosis observation period

次要结局

  • To increase the number of lungs really transplanted(end of brain death diagnosis observation period)
  • Interim analysis at 100 subjects enrolled will be considered(six months after transplant)

研究者

发起方
University of Turin, Italy
申办方类型
Other

研究点 (2)

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