Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT01126320
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2010-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated Patients Using the AnapnoGuard System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2010-05-15', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAP occurence', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Adverse events occurence', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VAP'], 'conditions': ['Ventilator Associated Pneumonia']}, 'descriptionModule': {'briefSummary': 'Ventilator Associated Pneumonia (VAP) is a common complication experienced by mechanically ventilated patients and within the framework of Respiratory Intensive Care Units. The AnapnoGuard system, developed by Hospitech Respiration Ltd. is a ventilation guard system that includes a number of unique characteristics. This study was designed to test the frequency VAP in mechanically ventilated ICU patients using the AnapnoGuard System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patients;\n* Patient was connected to AnapnoGuard system up to six hours from intubation;\n* Age - above 18.\n\nExclusion Criteria:\n\n* Pneumonia;\n* Aspiration Pneumonia;\n* Chronic or Severe Pneumonia;\n* Chronic Obstructive Pulmonary Disease (COPD) requiring permanent home-based antibiotic treatment;\n* Interstitial Lung Disease (ILD);\n* Post Lung Transplant State;\n* Immunosuppression.\n* Patients ventilated in prone position\n* Patient who was ventilated 3 months prior to being enrolled in the study\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT01126320', 'briefTitle': 'Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated Patients Using the AnapnoGuard System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hospitech Respiration'}, 'officialTitle': 'Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated ICU Patients Using the AnapnoGuard System', 'orgStudyIdInfo': {'id': 'HST -AG -02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AnapnoGuard 100', 'description': 'Respiratory guard system during mechanical ventilation', 'interventionNames': ['Device: AnapnoGuard 100,']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'routine mechanical ventilator', 'interventionNames': ['Device: routine mechanical ventilator']}], 'interventions': [{'name': 'AnapnoGuard 100,', 'type': 'DEVICE', 'description': 'Respiratory guard system during mechanical ventilation with routine mechanical ventilator', 'armGroupLabels': ['AnapnoGuard 100']}, {'name': 'routine mechanical ventilator', 'type': 'DEVICE', 'description': 'routine mechanical ventilation', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'RAMBAM Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Yaron Bar Lavi, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RAMBAM Medical Center, Haifa Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospitech Respiration', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}