Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-03 @ 11:00 PM
Study NCT ID:
NCT02968550
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2016-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shunt Evaluation With ALPE System in Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013896', 'term': 'Thoracic Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2016-11-08', 'studyFirstSubmitQcDate': '2016-11-15', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary shunt evaluated with ALPE system', 'timeFrame': 'every 30 minutes after the start of surgery up to 3 evaluations, up to 90 minutes'}], 'secondaryOutcomes': [{'measure': 'predictors of high intraoperative shunt', 'timeFrame': 'The outcome is assessed 15 minutes after one lung ventilation', 'description': 'All patients admitted to the study received a preoperative physiologic assessment with a cardiovascular evaluation and spirometry. After 15 minutes of one lung ventilation, the pulmonary shunt is evaluated. Therefore, all clinical variable evaluated during preoperative assessment will be compared with the pulmonary shunt'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mechanical Ventilation', 'Thoracic Diseases']}, 'referencesModule': {'references': [{'pmid': '11575407', 'type': 'BACKGROUND', 'citation': 'Beck DH, Doepfmer UR, Sinemus C, Bloch A, Schenk MR, Kox WJ. Effects of sevoflurane and propofol on pulmonary shunt fraction during one-lung ventilation for thoracic surgery. Br J Anaesth. 2001 Jan;86(1):38-43. doi: 10.1093/bja/86.1.38.'}]}, 'descriptionModule': {'briefSummary': '. The aim of this study, thus, is to evaluate shunt fraction and markers of alveolar distress during one lung ventilation (OLV) at different levels of positive end expiratory pressure (PEEP). Moreover, investigators will focus on predicting factors of high shunt levels during OLV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing thoracoscopic surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for thoracoscopic lobectomy or thoracoscopic wedge resection in lateral decubitus.\n* patients American Society of Anesthesiologists Physical Status Classification score of 1-3\n\nExclusion Criteria:\n\n* Patients with hemodynamic instability,\n* Patients with severe chronic respiratory failure\n* Patients with preoperative anemia (hemoglobin \\<10 g 100 ml-1)\n* Patients requiring unplanned conversion to thoracotomy'}, 'identificationModule': {'nctId': 'NCT02968550', 'briefTitle': 'Shunt Evaluation With ALPE System in Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Ferrara'}, 'orgStudyIdInfo': {'id': 'SEAT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low shunt group', 'description': 'patients with shunt less than 30% in one-lung ventilation at ZEEP'}, {'label': 'High shunt group', 'description': 'Patients with shunt equal or more than 30% in one-lung ventilation at ZEEP'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44121', 'city': 'Ferrara', 'country': 'Italy', 'facility': "Azienda Ospedaliero Universitaria Sant'Anna", 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Savino Spadaro', 'investigatorAffiliation': 'Università degli Studi di Ferrara'}}}}