Lung Transplant; Complications, Primary Graft Dysfunction
Conditions
Keywords
Lung Transplantation, Primary Graft Dysfunction, Mechanical Ventilation, Positive End-Expiratory Pressure, Electrical Impedance Tomography
Brief 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
Interventions
OTHERPEEP
After a recruitment maneuver three levels of PEEP (14\>10\>6cmH2O) will be tested
Sponsors
Policlinico Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Compliance | Measurements at three PEEP levels during a decremental PEEP trial | Identifying the level of PEEP associated to the best compliance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung collapse&overdistension | Measurements at three PEEP levels during a decremental PEEP trial | Identifying the level of PEEP associated to the lowest collapse&overdistension according to Electrical Impedance Tomography |
| Lung perfusion | Measurements at three PEEP levels during a decremental PEEP trial | Identifying the level of PEEP associated to the most homogeneous distribution of lung perfusion according to Electrical Impedance Tomography |
| Intrapulmonary shunt | Measurements at three PEEP levels during a decremental PEEP trial | Identifying the level of PEEP associated to the lowest intrapulmonary shunt level |
| Dead space | Measurements at three PEEP levels during a decremental PEEP trial | Identifying the level of PEEP associated to the lowest dead space fraction |
Countries
Italy
Outcome results
None listed