An interventional study of PEEP in Lung Transplant; Complications and Primary Graft Dysfunction, sponsored by Policlinico Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Policlinico Hospital · Not applicable, Interventional, and Treatment
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
26 studies on the registry are indexed under Primary Graft Dysfunction; 4 are open to participants now.
This study's enrollment of 47 is close to the median of 47 across 11 interventional studies indexed under Primary Graft Dysfunction.
Browse Primary Graft Dysfunction studies →Policlinico Hospital is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Within 48h after LuTX we will evaluate the effects of three levels of PEEP (14\>10\>6 cmH2O) upon: - lung and chest wall mechanics, - intrapulmonary shunt fraction; - distribution of ventilation and perfusion; - gas exchange.
Other: PEEP
After a recruitment maneuver three levels of PEEP (14\>10\>6cmH2O) will be tested
Lung Compliance
Identifying the level of PEEP associated to the best compliance
Time frame: Measurements at three PEEP levels during a decremental PEEP trial
Lung collapse&overdistension
Identifying the level of PEEP associated to the lowest collapse\&overdistension according to Electrical Impedance Tomography
Time frame: Measurements at three PEEP levels during a decremental PEEP trial
Lung perfusion
Identifying the level of PEEP associated to the most homogeneous distribution of lung perfusion according to Electrical Impedance Tomography
Time frame: Measurements at three PEEP levels during a decremental PEEP trial
Intrapulmonary shunt
Identifying the level of PEEP associated to the lowest intrapulmonary shunt level
Time frame: Measurements at three PEEP levels during a decremental PEEP trial
Dead space
Identifying the level of PEEP associated to the lowest dead space fraction
Time frame: Measurements at three PEEP levels during a decremental PEEP trial
Plan to share: Undecided — Deidentified data will be shared with other researchers upon explicit request
Ran from Jan 2023 to primary completion in Dec 2024, 23 months.
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Policlinico Hospital