Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-04 @ 5:31 AM
Study NCT ID:
NCT03282032
Status:
COMPLETED
Last Update Posted:
2018-11-30
First Post:
2017-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preconditioning of One-lung Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061810', 'term': 'One-Lung Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2017-09-08', 'studyFirstSubmitQcDate': '2017-09-10', 'lastUpdatePostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of hypoxemia', 'timeFrame': 'during one-lung ventilation, up to 5 hours', 'description': 'SpO2 \\< 95%'}, {'measure': 'P/F ratio', 'timeFrame': '30min after surgical incision', 'description': 'PaO2/FIO2 ratio'}], 'secondaryOutcomes': [{'measure': 'Pulmonary complications', 'timeFrame': '6, 24, 48 hours after surgery, during hospital stay.', 'description': 'Acute lung injury, acute respiratory distress syndrome, atelectasis, pneumonia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['One Lung Ventilation']}, 'referencesModule': {'references': [{'pmid': '6837992', 'type': 'BACKGROUND', 'citation': 'Benumof JL. Intermittent hypoxia increases lobar hypoxic pulmonary vasoconstriction. Anesthesiology. 1983 May;58(5):399-404. doi: 10.1097/00000542-198305000-00001.'}]}, 'descriptionModule': {'briefSummary': 'To observe the effect of one-lung ventilation (OLV) preconditioning on perioperative oxygenation during thoracic surgery.', 'detailedDescription': 'For lung isolation and better surgical view, one-lung ventilation(OLV) is essential for thoracic surgery. However, OLV may cause serious pulmonary complications due to intraoperative hypoxia.\n\nAnimal studies showed a positive effect of OLV preconditioning (Intermittent OLV before surgical intervention) on perioperative pulmonary oxygenation.\n\nThus, we designed a study to observe the effect of OLV preconditioning on perioperative oxygenation during thoracic surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective thoracic surgery which requires one-lung ventilation with lateral decubitus position\n\nExclusion Criteria:\n\n* Patients with severe cardiopulmonary disease, COPD, previous surgical history of pulmonary disease\n* Thoracic surgery for pneumonectomy'}, 'identificationModule': {'nctId': 'NCT03282032', 'briefTitle': 'Preconditioning of One-lung Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Preconditioning of One-lung Ventilation for Lung Protection', 'orgStudyIdInfo': {'id': 'JHSeo_preconditioning'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One-lung ventilation', 'description': 'Before surgical incision, 2-min of OLV followed by 2-min of TLV (1 cycle) is performed for 5 cycles.', 'interventionNames': ['Other: One-lung ventilation']}, {'type': 'NO_INTERVENTION', 'label': 'Two-lung ventilation', 'description': 'Maintain two-lung ventilation until surgical incision'}], 'interventions': [{'name': 'One-lung ventilation', 'type': 'OTHER', 'otherNames': ['Preconditioning'], 'description': 'The patient undergoing thoracic surgery is intubated with double lumen tube after induction of general anesthesia with propofol and remifentanil.\n\nIn the intervention group, 5 cycles of one-lung ventilation preconditioning (2-min of one-lung ventilation and 2-min of two-lung ventilation for 1 cycle) is performed before surgical incision. One-lung ventilation is done at dependent lung with FiO2 100% and tidal volume 6 ml kg-1. Two-lung ventilation is done with FiO2 50%, tidal volume 8 ml kg-1.', 'armGroupLabels': ['One-lung ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jeong-Hwa Seo, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong-Hwa Seo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}