Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT01513018
Status:
COMPLETED
Last Update Posted:
2012-01-20
First Post:
2012-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of High and Low Tidal Volumes on Arterial Oxygenation and Pulmonary Shunt During One-Lung Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-19', 'studyFirstSubmitDate': '2012-01-16', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'low (5ml/kg) tidal volume on arterial oxygenation', 'timeFrame': '30 minutes of ventillation', 'description': 'Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.'}, {'measure': 'high (10 ml/kg) tidal volumes on arterial oxygenation', 'timeFrame': '30 minutes of ventillation', 'description': 'Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.'}, {'measure': 'low (5 ml/kg)tidal volumes on Intrapulmonary shunt', 'timeFrame': '30 minutes of ventillation', 'description': 'Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.'}, {'measure': 'high (10 ml/kg) tidal volumes on Intrapulmonary shunt', 'timeFrame': '30 minutes of ventillation', 'description': 'Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.'}]}, 'conditionsModule': {'keywords': ['OLV', 'one lung ventilation'], 'conditions': ['Postoperative Lung Injury']}, 'descriptionModule': {'briefSummary': 'The ideal tidal volume (TV) during one-lung ventilation (OLV) remains controversial. High tidal volumes may increase the incidence of postoperative lung injury after thoracic surgery. The investigators thus evaluated the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during OLV.\n\nOne hundred patients scheduled for thoracic surgery were enrolled. During OLV, patients were randomly assigned to 30 minutes of ventilation with high TV (10 ml/kg with zero end-expiratory pressure (ZEEP)) at a rate of 10 breaths/minute or low tidal volume (5 ml/kg with 5 cm H2O positive end-expiratory pressure (PEEP)) at a rate of 20 breaths/minute. During the subsequent 30 minutes, each patient received the alternative management. Minute volume was thus kept constant during each experimental condition. Arterial blood partial pressures, hemodynamic responses, and ventilatory parameters were recorded. Results are presented as means ± SDs; P \\< 0.05 was considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III patients scheduled for lung resection surgery.\n\nExclusion Criteria:\n\n* severe cardiovascular disease\n* severe alteration of the preoperative pulmonary function, with FEV1 70-120% predicted and FEV1/FVC ≥ 70% predicted considered to be normal.'}, 'identificationModule': {'nctId': 'NCT01513018', 'briefTitle': 'Effects of High and Low Tidal Volumes on Arterial Oxygenation and Pulmonary Shunt During One-Lung Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'orgStudyIdInfo': {'id': 'DEOEC RKEB/IKEB 2976-2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'high (10 ml/kg) tidal volumes', 'description': 'Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.', 'interventionNames': ['Other: high tidal volumes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low tidal volume (5 ml/kg)', 'description': 'Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.', 'interventionNames': ['Other: low tidal volume']}], 'interventions': [{'name': 'high tidal volumes', 'type': 'OTHER', 'description': 'One-lung ventilation was started at skin incision using a volume-controlled square-wave flow pattern. Patients were randomly assigned to 30 minutes of ventilation with a tidal volume of 10 ml/kg tidal volume without external PEEP and respiratory rate of 10 breaths/minute (n=50) or to a tidal volume of 5 ml/kg with 5 cmH2O PEEP and a respiratory rate of 20 breaths/minute (n=50). Minute volume was thus kept constant during each experimental condition.\n\nRandomization was based on computer-generated codes that were maintained in sequentially numbered sealed opaque envelopes until after induction of anesthesia. During the subsequent 30 minutes of one-lung ventilation, the alternative ventilatory management was used.', 'armGroupLabels': ['high (10 ml/kg) tidal volumes']}, {'name': 'low tidal volume', 'type': 'OTHER', 'description': 'One-lung ventilation was started at skin incision using a volume-controlled square-wave flow pattern. Patients were randomly assigned to 30 minutes of ventilation with a tidal volume of 10 ml/kg tidal volume without external PEEP and respiratory rate of 10 breaths/minute (n=50) or to a tidal volume of 5 ml/kg with 5 cmH2O PEEP and a respiratory rate of 20 breaths/minute (n=50). Minute volume was thus kept constant during each experimental condition.\n\nRandomization was based on computer-generated codes that were maintained in sequentially numbered sealed opaque envelopes until after induction of anesthesia. During the subsequent 30 minutes of one-lung ventilation, the alternative ventilatory management was used.', 'armGroupLabels': ['low tidal volume (5 ml/kg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'University of Debrecen, Medical and Health Science CenterDepartment of Anesthesiology and Intensive Care', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}], 'overallOfficials': [{'name': 'Tamás Végh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Ludwigshafen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}