Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT05691205
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2023-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identifying Optimal PEEP After Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055031', 'term': 'Primary Graft Dysfunction'}], 'ancestors': [{'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Compliance', 'timeFrame': 'Measurements at three PEEP levels during a decremental PEEP trial', 'description': 'Identifying the level of PEEP associated to the best compliance'}], 'secondaryOutcomes': [{'measure': 'Lung collapse&overdistension', 'timeFrame': 'Measurements at three PEEP levels during a decremental PEEP trial', 'description': 'Identifying the level of PEEP associated to the lowest collapse\\&overdistension according to Electrical Impedance Tomography'}, {'measure': 'Lung perfusion', 'timeFrame': 'Measurements at three PEEP levels during a decremental PEEP trial', 'description': 'Identifying the level of PEEP associated to the most homogeneous distribution of lung perfusion according to Electrical Impedance Tomography'}, {'measure': 'Intrapulmonary shunt', 'timeFrame': 'Measurements at three PEEP levels during a decremental PEEP trial', 'description': 'Identifying the level of PEEP associated to the lowest intrapulmonary shunt level'}, {'measure': 'Dead space', 'timeFrame': 'Measurements at three PEEP levels during a decremental PEEP trial', 'description': 'Identifying the level of PEEP associated to the lowest dead space fraction'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Transplantation', 'Primary Graft Dysfunction', 'Mechanical Ventilation', 'Positive End-Expiratory Pressure', 'Electrical Impedance Tomography'], 'conditions': ['Lung Transplant; Complications', 'Primary Graft Dysfunction']}, 'referencesModule': {'references': [{'pmid': '23306540', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19001507', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '19255741', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nActual 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.\n\nIn 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.\n\nThe final aim is to find the optimal level of PEEP in this patient's cohort"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipient of LUTX\n* Age \\> 18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Already undergone LUTX\n* 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)\n* Documented post-LUTX endobronchial plasma leak requiring high levels of PEEP \\> 15 cmH2O'}, 'identificationModule': {'nctId': 'NCT05691205', 'acronym': 'PEEP-LuTX', 'briefTitle': 'Identifying Optimal PEEP After Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'Identifying the Optimal Positive End-Expiratory Pressure Level to Ventilate Patients After Bilateral Lung Transplantation', 'orgStudyIdInfo': {'id': '0058711-U'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEEP-LuTX', 'description': '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.', 'interventionNames': ['Other: PEEP']}], 'interventions': [{'name': 'PEEP', 'type': 'OTHER', 'description': 'After a recruitment maneuver three levels of PEEP (14\\>10\\>6cmH2O) will be tested', 'armGroupLabels': ['PEEP-LuTX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'Milan', 'country': 'Italy', 'facility': "Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Deidentified data will be shared with other researchers upon explicit request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Giacomo Grasselli', 'investigatorAffiliation': 'Policlinico Hospital'}}}}