Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-09 @ 8:32 PM
Study NCT ID:
NCT02553057
Status:
UNKNOWN
Last Update Posted:
2015-09-17
First Post:
2015-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Tidal Volume for Lung Protection During Anesthesia of Laparoscopic Surgery in Trendlenburg Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012121', 'term': 'Respiration, Artificial'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-16', 'studyFirstSubmitDate': '2015-09-15', 'studyFirstSubmitQcDate': '2015-09-16', 'lastUpdatePostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pulmonary complications', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intraoperative Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'Mechanical ventilation of patients undergoing laparoscopic surgery may induce lung injury. Since lung protective ventilation has been recommended during anesthesia to prevent ongoing lung injury, so in our study the investigators will compare three different lung protective strategies regarding their lung protective effect measured by the incidence of postoperative pulmonary complications, perioperative oxygenation and postoperative inflammatory mediator release.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients undergoing laparoscopic colorectal or gynaecologic surgery with expected time more than two hours\n\nExclusion Criteria:\n\n* refusal, preoperative pulmonary disease'}, 'identificationModule': {'nctId': 'NCT02553057', 'acronym': 'lapVent', 'briefTitle': 'Low Tidal Volume for Lung Protection During Anesthesia of Laparoscopic Surgery in Trendlenburg Position', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'orgStudyIdInfo': {'id': 'DrSamah'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'mechanical ventilation with Tidal volume 4 ml/kg and PEEP 8-10 cm H2o', 'interventionNames': ['Device: mechanical ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group2', 'description': 'mechanical ventilation with Tidal volume 6 ml/kg and PEEP 8-10 cm H2o', 'interventionNames': ['Device: mechanical ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'mechanical ventilation with Tidal volume 8 ml/kg and PEEP 8-10 cm H2o', 'interventionNames': ['Device: mechanical ventilation']}], 'interventions': [{'name': 'mechanical ventilation', 'type': 'DEVICE', 'armGroupLabels': ['Group 1', 'Group 3', 'Group2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'state': 'Dkahleya', 'country': 'Egypt', 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AlRefaey Kandeel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'AlRefaey Kandeel', 'investigatorAffiliation': 'Mansoura University'}}}}