Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-31 @ 7:04 AM
Study NCT ID:
NCT03806504
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2019-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High PEEP Application Following Pulmonary Thromboendarterectomy; Does it Have Any Impact on Outcome?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2019-01-15', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'free oxygen radicals levels', 'timeFrame': '48 hours', 'description': 'Superoxide dismutase (SOD) activity will be measured by modification of the method of Sun et al. and Protein carbonyl groups will be determined by volume modification according to Reznick and Packer method.'}], 'secondaryOutcomes': [{'measure': 'postoperatif outcome - Duration of stay in the intensive care unit and hospital stay', 'timeFrame': '10 day', 'description': 'Duration of stay in the intensive care unit and hospital stay after pte operation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic thromboembolic pulmonary hypertension', 'PEEP', 'reperfusion injury'], 'conditions': ['Reperfusion Injury After Pulmonary Thromboendarterektomy']}, 'descriptionModule': {'briefSummary': 'Investigation of the effect of intraoperative lung protection high PEEP maneuver on ischemic reperfusion injury in patients undergoing pulmonary endarterectomy.', 'detailedDescription': 'Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare disease characterized by progression of thromboembolism obstructing pulmonary arteries as an organized tissue. Pulmonary thromboendarterectomy (PTE) is a treatment option for chronic thromboembolic pulmonary disease. However, PTE is associated with specific postoperative complications, such as pulmonary edema and right ventricular failure due to reperfusion injury, with a significant mortality rate of 7% to 24%. Some strategies have been proposed to reduce lung injury after PTE, such as rectification maneuvers and high PEEP. The aim of this study was to investigate the effect of intraoperative lung protection high PEEP maneuver in patients undergoing pulmonary endarterectomy for ischemic reperfusion injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective PTE operation due to CTEPH,\n* 20-70 years old\n\nExclusion Criteria:\n\n* Patients with chronic inflammatory disease,\n* liver and renal failure,\n* heart failure (\\<EF: 40%),\n* intraoperative bronchial hemorrhage,\n* patients undergoing postoperative revision.'}, 'identificationModule': {'nctId': 'NCT03806504', 'briefTitle': 'High PEEP Application Following Pulmonary Thromboendarterectomy; Does it Have Any Impact on Outcome?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital'}, 'officialTitle': 'Prospective Randomized Trial of Impact of High PEEP Application Following Pulmonary Endarterectomy on Outcome', 'orgStudyIdInfo': {'id': '2018/6/62'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'high PEEP', 'description': '35 cm/H2O PEEP, 2-3 ml/kg tidal volume,45 seconds, after cardiopulmonary bypass', 'interventionNames': ['Other: PEEP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': '6 cm/H2O PEEP, 6-8 ml/kg tidal volume, continues, after cardiopulmonary bypass', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'PEEP', 'type': 'OTHER', 'description': 'performing 35 cm/H2O PEEP and 2-3 ml/kg tidal volume', 'armGroupLabels': ['high PEEP']}, {'name': 'control group', 'type': 'OTHER', 'description': 'performing 6 cm/H2O PEEP and 6-8 ml/kg tidal volume', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34865', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Mustafa EMRE Gurcu', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'anesthesia and reanimation specialist', 'investigatorFullName': 'mustafa emre gürcü', 'investigatorAffiliation': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital'}}}}