Identifying Optimal PEEP After Lung Transplantation (NCT05691205) | Clinical Trial Compass
CompletedNot Applicable
Identifying Optimal PEEP After Lung Transplantation
Italy47 participantsStarted 2023-01-31
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lung Compliance
Timeframe: Measurements at three PEEP levels during a decremental PEEP trial