Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT02483806
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2015-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Positive End-Expiratory Pressure on Biventricular Function During One-Lung Ventilation
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-26', 'studyFirstSubmitDate': '2015-06-19', 'studyFirstSubmitQcDate': '2015-06-24', 'lastUpdatePostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the effect of differential PEEP (0, 5, 10 cmH2O) by PaO2(P/F ratio)', 'timeFrame': '20 minutes after each PEEP apply'}, {'measure': 'Cardiac function', 'timeFrame': '20 minutes after each PEEP apply', 'description': 'cardiac function : Tei index'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary shunt can be increased resulting hypoxemia. Wang et al measured intrapulmonary shunt by transesophageal echocardiography. Although OLV technique had been advanced so far, hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Applying PEEP(Positive End-expiratory Pressure) at dependent lung and CPAP at non-dependent lung can mitigate the hypoxemia. Above all, PEEP can be easily applicable. However, there are controversial studies whether it is supportive or not. In this prospective, cross-over study, the investigators are planning to investigate the effects of PEEP on intrapulmonary shunt, oxygenation and cardiac function as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for VATS lobectomy\n* 40 ≤ age ≤ 80\n* American Society of Anaesthesiologists(ASA) physical status classification I\\~III\n\nExclusion Criteria:\n\n* American Society of Anaesthesiologists(ASA) physical status classification IV\n* NYHA class III\\~IV\n* Severe obstructive lung disease and/or restrictive lung disease patients\n* those with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)\n* arrhythmia\n* esophageal varix\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT02483806', 'briefTitle': 'Effects of Positive End-Expiratory Pressure on Biventricular Function During One-Lung Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effects of Positive End-Expiratory Pressure on Biventricular Function During One-Lung Ventilation: a Randomized Crossover Study', 'orgStudyIdInfo': {'id': '4-2015-0325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEEP 0 cmH2O', 'description': 'PEEP 0 cmH2O (zero end expiratory pressure, ZEEP)', 'interventionNames': ['Procedure: PEEP']}, {'type': 'EXPERIMENTAL', 'label': 'PEEP 5 cmH2O', 'interventionNames': ['Procedure: PEEP']}, {'type': 'EXPERIMENTAL', 'label': 'EEP 10 cmH2O', 'interventionNames': ['Procedure: PEEP']}], 'interventions': [{'name': 'PEEP', 'type': 'PROCEDURE', 'otherNames': ['Positive EndExpiratory Pressure breathing(PEEP)'], 'description': 'After induction of anesthesia, including insertion of TEE probe, change position from supine to lateral position. Measure ABGA and cardiac indices for the baseline value. Apply each PEEP (0, 5, 10 cmH2O) serially at the random order. 6 sequences (0-\\>5-\\>10, 0-\\>10-\\>5, 5-\\>10-\\>0, 5-\\>0-\\>10, 10-\\>5-\\>0, 10-\\>0-\\>5) are equally applied to 6 patients (total 6x6=36 patients) who agreed to this study. Measure ABGA and cardiac indices after 20 min at each step of peep apply(3 times).', 'armGroupLabels': ['EEP 10 cmH2O', 'PEEP 0 cmH2O', 'PEEP 5 cmH2O']}]}, '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}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}