跳至主要内容
临床试验/NCT06159933
NCT06159933已完成不适用

Early Prone Positioning as a Rescue Therapy for Severe Primary Graft Dysfunction After Bilateral Lung Transplant.

University of Padova2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
试验地点
2
主要终点
28-day ventilator free days

研究概览

简要总结

Proning manoeuvre as an early treatment for acute severe hypoxic respiratory failure has been implemented recently during the COVID-19 pandemic. This method was proposed more than fifty years ago to improve gas exchange : Proning Severe ARDS (PROSEVA) trial, however, was the milestone which demonstrated mortality benefit in patients with severe ARDS. Nevertheless, few analysis were performed on the effects of the prone position after lung transplantion (LT). The aim of the study is therefore to relate LT primary graft dysfunction (PGD) pathophysiology, which occurs in postoperative setting, to prone-positioning effects on ventilation-perfusion matching, improved lung compliance and clinical outcomes of impairedorgan patients.

详细描述

Lung transplant is the final stage of intervention in dramatic respiratory failure unresponsive to other medical or surgical treatments: reduced disability, improved life quality and extended life are outweighed by still high mortality and morbidity of LT, compared to other solid organs transplants. LT patient survival is undermined, above all, by PGD onset up to 72h in postoperative scenario. Acute lung injury, characterized by reperfusion and ischemia damage, evolves in pulmonary edema and severely inflammed graft status. Tipical radiological findings are bilateral spreading infiltrates, whose treatment was until some years ago mainly supportive, i.e. protective mechanical ventilation and fluid restriction. Two retrospective studies recently demonstrated favorable oxygenation response in terms of PaO2/fraction-of-inspired-oxygen (FiO2) ratio and lung compliance. Our purpose was to broaden gas-exchange results by the analysis of short-term outcomes (i.e duration of mechanical ventilation, reintubation or tracheostomy, anastomotical complications, organ rejection in 30 days, acute kindney injury development and/or filtration necessity, hospital length and mortality). Our aim is to assess through this pilot study if early pronation (realized within 24 hours from admission) has a more favorable outcome on patients developing moderate/severe PGD within the first 24 postoperative hours.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Age > 18 y.o.
  • First bilateral lung transplant
  • PGD grade 2 or 3 within 24 hours from ICU admission Admission to ICU for post-operative monitoring after LTx
  • Written informed consent obtained

排除标准

  • Age < 18 years old
  • Single transplant
  • Re-transplant
  • IMV, venous-venous (V-V) or venous-arterial (V-A) extracorporeal membrane oxygenation (ECMO) before surgery
  • Contraindications to prone positioning
  • Refusal of consent

结局指标

主要结局

28-day ventilator free days

时间窗: From ICU admission up to 28 post-operative days (POD)

Days free from invasive mechanical ventilation after lung transplant

次要结局

  • Invasive mechanical ventilation (IMV)(From ICU adminission up to liberation from invasive mechanical ventilation)
  • Blood gas exchanges (PaO2 /FiO2 PaCo2, pH)(Within 24hours from ICU admission, at 72 hours later, in supine and prone position)

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

Annalisa Boscolo

Doctor

University of Padova

研究点 (2)

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