Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-25 @ 12:46 PM
Study NCT ID:
NCT01630395
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2012-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2012-06-21', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of IL-8, TNFa in the bronchoalveolar lavage', 'timeFrame': 'up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery'}], 'secondaryOutcomes': [{'measure': 'Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage', 'timeFrame': 'up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery'}, {'measure': 'plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa', 'timeFrame': 'up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery'}, {'measure': 'oxygenation', 'timeFrame': '1 hour after extubation', 'description': 'Changes in PaO2/FIO2 ratio'}, {'measure': 'Chest-X ray', 'timeFrame': '7 days after surgery'}]}, 'conditionsModule': {'conditions': ['Mechanical Ventilation Complication', 'Thoracic Surgery', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 Years and older\n* Patients undergoing thoracic surgery\n\nExclusion Criteria:\n\n* Emergency surgery\n* Heart failure\n* Pulmonary hypertension\n* Forced vital capacity or forced expiratory volume in 1 sec \\< 50% of the predicted values\n* Coagulation disorder\n* Pulmonary or extrapulmonary infections\n* History of treatment with steroid in 3 months before surgery\n* History of recurrent pneumothorax\n* History of lung resection surgery'}, 'identificationModule': {'nctId': 'NCT01630395', 'briefTitle': 'The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Recruitment Maneuver With Protective Ventilation on the Pulmonary and Systemic Inflammatory Response to One-lung Ventilation', 'orgStudyIdInfo': {'id': 'JHBahk_recruitment maneuver'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'conventional', 'description': 'Two-lung ventilation: tidal volume = 10 ml/kg, no PEEP. One-lung ventilation: tidal volume = 10 ml/kg, no PEEP'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Protective', 'description': 'Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O.', 'interventionNames': ['Procedure: protective ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Recruitment', 'description': 'Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O. Recruitment maneuver will be applied during one-lung ventilation.', 'interventionNames': ['Procedure: Recruitment maneuver combined with protective ventilation']}], 'interventions': [{'name': 'protective ventilation', 'type': 'PROCEDURE', 'description': 'low tidal volume and PEEP', 'armGroupLabels': ['Protective']}, {'name': 'Recruitment maneuver combined with protective ventilation', 'type': 'PROCEDURE', 'description': 'Low tidal volume, PEEP and recruitment maneuver', 'armGroupLabels': ['Recruitment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}