Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-01-01 @ 1:09 AM
Study NCT ID:
NCT01499212
Status:
COMPLETED
Last Update Posted:
2011-12-26
First Post:
2011-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different I:E Ratio on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-21', 'studyFirstSubmitDate': '2011-12-18', 'studyFirstSubmitQcDate': '2011-12-21', 'lastUpdatePostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intrapulmonary shunt fraction', 'timeFrame': 'T1 (10min before one lung ventibation)T2 (30min after one lung ventilation started)T3 (60min after one lung ventilation started)T4 (10min after two lung ventilation)', 'description': 'T1,T2,T3,T4 : ALL mesurement in lateral decubitus position T1-intrapulmonary shunt T2-intrapulmonary shunt T3-intrapulmonary shunt T4-intrapulmonary shunt'}], 'secondaryOutcomes': [{'measure': 'Respiratory dynamic parameters', 'timeFrame': 'T1,T2,T3,T4 (same as primary outcome measure)', 'description': 'Mechanical Ventilator measurement : Paw, Pplat, Pmean, Compliance'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Lung Lobectomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate effect of increasing inspiratory time (I:E ratio 1:1) on intrapulmonary shunt fraction and oxygenation during one lung ventilation in the lateral decubitus position.', 'detailedDescription': 'Increasing inspiratory time(e.g. Inverse ratio ventilation) has been known that had advantage of alveolar recruitment, preventing of ateletasis. On the contrary, it has disadvantange of intrinsic PEEP, air trapping. There is few study on one lung ventilation in lateral decubitus position about this ventilation method. We were going to investigate effecf of this ventilation method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status class I, II\n* Use of Double lumen tube\n* Unilateral lung lobectomy\n\nExclusion Criteria:\n\n* COPD\n* CAOD\n* Unstable hemodynamic status\n* Peak airway pressure \\> 30mmHg (Two lung ventilation)'}, 'identificationModule': {'nctId': 'NCT01499212', 'briefTitle': 'Effects of Different I:E Ratio on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effects of Different Inspiratory to Expiratory Ratios on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position', 'orgStudyIdInfo': {'id': '1-2011-0058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I:E ratio 1:1', 'interventionNames': ['Procedure: I:E ratio']}], 'interventions': [{'name': 'I:E ratio', 'type': 'PROCEDURE', 'description': 'I:E ratio 1:1 Volume controlled ventilation TV:8ml/kg EtCO2:35-40mmHg', 'armGroupLabels': ['I:E ratio 1:1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young Jun Oh, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}