Identifying Optimal PEEP After Lung Transplantation

Study Overview
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Brief Summary
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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

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

Conditions
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Lung Transplant; Complications, Primary Graft Dysfunction

Intervention / Treatment
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* Other: PEEP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEP-LuTX<br>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<br>* After a recruitment maneuver three levels of PEEP (14>10>6cmH2O) will be tested<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Compliance | Identifying the level of PEEP associated to the best compliance | Measurements at three PEEP levels during a decremental PEEP trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung collapse&overdistension | Identifying the level of PEEP associated to the lowest collapse&overdistension according to Electrical Impedance Tomography | 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 | Measurements at three PEEP levels during a decremental PEEP trial | 
| Intrapulmonary shunt | Identifying the level of PEEP associated to the lowest intrapulmonary shunt level | Measurements at three PEEP levels during a decremental PEEP trial | 
| Dead space | Identifying the level of PEEP associated to the lowest dead space fraction | Measurements at three PEEP levels during a decremental PEEP trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Transplantation, Primary Graft Dysfunction, Mechanical Ventilation, Positive End-Expiratory Pressure, Electrical Impedance Tomography