Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-26 @ 12:31 PM
Study NCT ID:
NCT02074306
Status:
UNKNOWN
Last Update Posted:
2018-08-07
First Post:
2014-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does UROSHIELD® Influence Bacterial Growth On Endotracheal Tubes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-05', 'studyFirstSubmitDate': '2014-02-13', 'studyFirstSubmitQcDate': '2014-02-26', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days elapse until development of positive sputum culture', 'timeFrame': '15-20 days', 'description': 'Sputum for culture will be obtained every 3 days. Number of days till sputum culture will convert from negative to positive one will be calculated and compared for the study and control groups.'}], 'secondaryOutcomes': [{'measure': 'Type of bacteria and antibiotic sensitivity', 'timeFrame': '15-20 days', 'description': 'Types of bacteria and their sensitivities to antibiotics will be evaluated. Comparison will be done between rate of growth of serious pathogens (e.g., Methicillin resistant staphylococcus aureus (MRSA),Vancomycin-Resistant Enterococci (VRE)) in the study and control groups.\n\nRate of resistance development to antibiotics will also be compared.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endotracheal intubation', 'low energy ultrasound', 'sputum culture'], 'conditions': ['Mechanical Ventilation Complication']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effect of UROSHIELD® (a device which generates low energy ultrasound waves) on development of bacterial colonies on endotracheal tubes, in patient receiving mechanical ventilation, and to determine whether this device lowers the rate of bacterial resistance to antibiotics.', 'detailedDescription': 'Ventilator Associated Pneumonia (VAP) is a common complication in patients treated by mechanical ventilation, supposedly related to development of bacterial colonization on the endotracheal tubes. Therefore many devices were designed to address this issue.\n\nNanovibronixTM Company developed "UROSHIELD®" a device which generates low energy ultrasound wave in the nanometer range, and delivers these waves by an actuator which is connected externally to a urinary catheter. It was shown that using UROSHIELD®, there was reduction in development of bacterial colonies, and lower rate of resistance of bacteria to antibiotics.\n\nAim of the study:\n\nTo examine the effect of UROSHIELD® on development of bacterial colonies on endotracheal tubes, in patient receiving mechanical ventilation, and to determine whether this device lowers the rate of bacterial resistance to antibiotics.\n\nMethods:\n\nConsecutive patients, with newly begun mechanical ventilation, will be connected to UROSHIELD® within 48 hours. Endotracheal secretions will be collected for culture and antibiotic sensitivity every 3 days for 15 consecutive days or until disconnection from the mechanical ventilation. Half of the devices will be active for the study group; the other half will be sham for the control. The devices will externally look identical and will have a serial number which will remain secret.\n\nPrimary end point: The time to convert the sputum culture from negative to positive.\n\nSecondary end points: The number of positive cultures with virulent bacteria and the rate of development of resistance to antibiotics will also be compared.\n\nBy statistical analysis the investigators conclude that enrollment of 33 patients into each group will allow significant results to be detected.\n\nShould the study group show longer time to convert to positive bacterial culture and/or lower antibiotic resistance, the use of UROSHIELD®, should be examined in a larger study, with reduction of VAP as a primary end point.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive adult patients, with newly begun mechanical ventilation, will be connected to UROSHIELD® within 48 hours\n\nExclusion Criteria:\n\n* Pediatric patients'}, 'identificationModule': {'nctId': 'NCT02074306', 'acronym': 'lungshield', 'briefTitle': 'Does UROSHIELD® Influence Bacterial Growth On Endotracheal Tubes', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Does UROSHIELD® Influence Bacterial Growth On Endotracheal Tubes', 'orgStudyIdInfo': {'id': '109/13'}, 'secondaryIdInfos': [{'id': 'SZMCenter IRB', 'type': 'OTHER', 'domain': 'Shaare Zedek Medical Center IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UROSHIELD®', 'description': 'Randomly selected patients,(ratio 1:1) with newly begun mechanical ventilation, will be connected to a low energy acustic wave generator UROSHIELD® within 48 hours. Endotracheal secretions will be collected for culture and antibiotic sensitivity every 3 days for 15 consecutive days or until disconnection from the mechanical ventilation.', 'interventionNames': ['Device: UROSHIELD®']}, {'type': 'SHAM_COMPARATOR', 'label': 'SHAM UROSHIELD®', 'description': 'same as abouve but with Sham device.', 'interventionNames': ['Device: SHAM UROSHIELD®']}], 'interventions': [{'name': 'UROSHIELD®', 'type': 'DEVICE', 'otherNames': ['LUNGSHIELD®'], 'description': 'An active UROSHIELD® device (low energy acustic wave generator) will be connected to an intratracheal tube externally. The device will transform low energy ultrasound waves on to the tube. These waves will by assumption lower the formation of bacterial growth and resistance to antibiotics.', 'armGroupLabels': ['UROSHIELD®']}, {'name': 'SHAM UROSHIELD®', 'type': 'DEVICE', 'otherNames': ['SHAM LUNGSHIELD®'], 'description': 'SHAM UROSHIELD® will be connected to endotracheal tubes unable to transform any waves.', 'armGroupLabels': ['SHAM UROSHIELD®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9103102', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Reuven Friedmann, Dr', 'role': 'CONTACT', 'email': 'reufri@szmc.org.il', 'phone': '972508685156'}, {'name': 'Reuven Friedmann, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical wing, Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Reuven Friedmann, Dr', 'role': 'CONTACT', 'email': 'reufri@szmc.org.il', 'phone': '+972508685156'}], 'overallOfficials': [{'name': 'Reuven Friedmann, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shaare Zedek Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of geriatric ward', 'investigatorFullName': 'REUVEN FRIEDMANN', 'investigatorAffiliation': 'Shaare Zedek Medical Center'}}}}