Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEEP-LuTX | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEEP | Other | After a recruitment maneuver three levels of PEEP (14>10>6cmH2O) will be tested |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico | Milan | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23306540 | Background | Diamond JM, Lee JC, Kawut SM, Shah RJ, Localio AR, Bellamy SL, Lederer DJ, Cantu E, Kohl BA, Lama VN, Bhorade SM, Crespo M, Demissie E, Sonett J, Wille K, Orens J, Shah AS, Weinacker A, Arcasoy S, Shah PD, Wilkes DS, Ware LB, Palmer SM, Christie JD; Lung Transplant Outcomes Group. Clinical risk factors for primary graft dysfunction after lung transplantation. Am J Respir Crit Care Med. 2013 Mar 1;187(5):527-34. doi: 10.1164/rccm.201210-1865OC. Epub 2013 Jan 10. | |
| 19001507 |
Not provided
Not provided
Deidentified data will be shared with other researchers upon explicit request
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055031 | Primary Graft Dysfunction |
| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Background |
| Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11. |
| 19255741 | Background | Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |