Primary Graft Dysfunction, Pronation, Bilateral Lung Transplants

Lung Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06159933
• Other study ID #: reference 4539/AO/18
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 15, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Age < 18 years old

• PGD<2

• 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

Related Conditions & MeSH terms

• Lung Transplant
• Primary Graft Dysfunction

Intervention

Procedure:
• Supine positioning
According to our local protocol, until December 2021, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group).
• Early pronation
According to our local protocol, starting from January 2022, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group).
• Late pronation
According to our local protocol, until December 2021, all patients developing PGD >1 after LT were monitored in supine position for at least 24 hours, aiming at optimizing mechanical ventilation settings and right ventricular function, before considering PP. Only in case of radiological worsening or reduction in PaO2/FiO2 ratio patients were turned prone, generally between 24 and 48 hours after the diagnosis ('late PP' group), otherwise they were maintained supine ('supine' group).

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Università Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day ventilator free days	Days free from invasive mechanical ventilation after lung transplant	From ICU admission up to 28 post-operative days (POD)
Secondary	Invasive mechanical ventilation (IMV)	Duration of IMV	From ICU adminission up to liberation from invasive mechanical ventilation
Secondary	Blood gas exchanges (PaO2 /FiO2 PaCo2, pH)	Emogas analysis	Within 24hours from ICU admission, at 72 hours later, in supine and prone position