Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06159933 |
Other study ID # |
reference 4539/AO/18 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2020 |
Est. completion date |
November 15, 2023 |
Study information
Verified date |
January 2024 |
Source |
University of Padova |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.