NCT06159933

Primary Graft Dysfunction, Pronation, Bilateral Lung Transplants

Completed NA Last updated 1 February 2024

What this trial tests

NA trial testing Supine positioning in Lung Transplant in 67 participants. Completed in 15 November 2023.

Timeline

1 January 2020

Primary endpoint
30 April 2023

15 November 2023

Quick facts

Lead sponsor	University of Padova
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	67
Start date	1 January 2020
Primary completion	30 April 2023
Estimated completion	15 November 2023
Sites	1 location across Italy

Drugs / interventions tested

• Supine positioning
• Early pronation
• Late pronation

Conditions studied

• Lung Transplant — all drugs for Lung Transplant →
• Primary Graft Dysfunction — all drugs for Primary Graft Dysfunction →

Sponsor

University of Padova

Who can join

18 and older, any sex, with Lung Transplant or Primary Graft Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.