Primary Graft Dysfunction, Pronation, Bilateral Lung Transplants

NCT06159933 | Completed

• 1 other identifier: reference 4539/AO/18
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Transplant; Primary Graft Dysfunction

Keywords

pronation, end-stage lung disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

Historic cohort (SUPINE POSITIONING)

EXPERIMENTAL

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).

Procedure: Supine positioning

Historic cohort (LATE PRONATION)

EXPERIMENTAL

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).

Procedure: Late pronation

Prospective cohort (EARLY PRONATION)

EXPERIMENTAL

On the contrary, starting from January 2022 our local protocol was updated and all LT recipients developing PGD \>1 were routinely turned prone within 24 hours after the diagnosis ('early PP').Patients were placed in PP for at least 16 hours before being turned back to the supine position when meeting predefined criteria previously published by Guèrin et al

Procedure: Early pronation

Interventions

Supine positioning PROCEDURE

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).

Historic cohort (SUPINE POSITIONING)

Early pronation PROCEDURE

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).

Prospective cohort (EARLY PRONATION)

Late pronation PROCEDURE

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).

Historic cohort (LATE PRONATION)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Azienda Ospedaliera Università Padova

Padua, 35126, Italy

Location

MeSH Terms

Conditions

Primary Graft Dysfunction

Condition Hierarchy (Ancestors)

Reperfusion Injury; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Historic cohort enrolled between January 2020 and December 2021; Prospective enrollment from January 2022 to April 2023. 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). On the contrary, starting from January 2022 our local protocol was updated and all LT recipients developing PGD \>1 were routinely turned prone within 24 hours after the diagnosis ('early PP').Patients were placed in PP for at least 16 hours before being turned back to the supine position when meeting predefined criteria previously published by Guèrin et al.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 7, 2023
• Study Start: January 1, 2020
• Primary Completion: April 30, 2023
• Study Completion: November 15, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)