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COMPLETEDNA

Identifying Optimal PEEP After Lung Transplantation

Identifying the Optimal Positive End-Expiratory Pressure Level to Ventilate Patients After Bilateral Lung Transplantation

NCT05691205•Policlinico Hospital

View on ClinicalTrials.gov

Summary

Lung Transplantation (LuTX) is the curative treatment for selected patients with end-stage lung disease. Primary Graft Dysfunction (PGD), a specific form of respiratory failure occurring within the first 72 hours after graft reperfusion, represents the most common complication after LuTX. Actual recommendation regarding management of mechanical ventilation of the lung graft immediately after LuTX are based only on opinion experts and not on clinical trials. Optimization of Positive End-Expiratory Pressure might contribute to both prevention and treatment of PGD. In this interventional single-center non-pharmacological study (with medical device), in the immediate postoperative period of patients who are undergone LuTX, we will evaluate the effects of varying levels of PEEP upon: - lung and chest wall mechanics, - intrapulmonary shunt fraction; - distribution of ventilation and perfusion; - gas exchange. The final aim is to find the optimal level of PEEP in this patient's cohort

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Recipient of LUTX
•Age \> 18 years
•Signed informed consent

Exclusion Criteria

•Age \< 18 years
•Already undergone LUTX
•Major hemodynamic instability along the 24 hours following LUTX: systolic arterial pressure \< 90 mmHg and/or heart rate \> 120 beat/min and/or high dose vasopressor requirement (norepinephrine \> 0.3 mcg/kg/min and/or epinephrine \> 0.2 mcg/kg/min and/or dobutamine \> 8mcg/kg/min)
•Documented post-LUTX endobronchial plasma leak requiring high levels of PEEP \> 15 cmH2O

Locations (1)

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, Milan, Italy

Key Dates

Start Date

January 31, 2023

Primary Completion Date

December 31, 2024

Completion Date

March 15, 2025

Last Updated

April 2, 2025

Enrollment

ACTUAL participants

Conditions

Lung Transplant; ComplicationsPrimary Graft Dysfunction

Interventions

PEEP

OTHER

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Identifying Optimal PEEP After Lung Transplantation

Inclusion Criteria

Exclusion Criteria

Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation

An Evaluation of Remote Care (questionnaire+hybrid) in Patients Who Are Post-lung Transplant

RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant

Assessment of Lung Transplant Recipients Within The Scope of International Classification of Functioning, Disability and Health

Prophylactic Topical Epinephrine to Reduce Bleeding in Transbronchial Lung Biopsies

COVID19 Vaccine in SOT Adult Recipients