Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT02277418
Status:
COMPLETED
Last Update Posted:
2014-11-14
First Post:
2014-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Venner a.p. Advance Video Laryngoscope
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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2014-10-27', 'studyFirstSubmitQcDate': '2014-10-27', 'lastUpdatePostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to intubation', 'timeFrame': '1 day', 'description': 'time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.'}], 'secondaryOutcomes': [{'measure': 'Success of intubation', 'timeFrame': '1 day', 'description': 'effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations.'}, {'measure': 'POGO score', 'timeFrame': '1 day', 'description': 'self-reported percentage of glottis opening (POGO) score'}, {'measure': 'VAS score', 'timeFrame': '1 day', 'description': 'participants were asked which method they would prefer in a real-life resuscitation.'}, {'measure': 'Cormack-Lehan scale', 'timeFrame': '1 day', 'description': 'self reported Cormack-Lehan scale during intubation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intubation', 'Resuscitation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the Venner a.p. advance video laryngoscope to Miller laryngoscope during resuscitation with and without chest compressions.', 'detailedDescription': 'Endotracheal intubation (ETI) is a life-saving procedure performed daily in emergency medicine. The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. However, ETI with uninterrupted chest compression in patients can be a very difficult skill to acquire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* give voluntary consent to participate in the study\n* minimum 1 year of work experience in emergency medicine\n* experienced emergency medical personnel (paramedics, nurses, physicians\n\nExclusion Criteria:\n\n* not meet the above criteria\n* wrist or low back diseases'}, 'identificationModule': {'nctId': 'NCT02277418', 'acronym': 'VAVL', 'briefTitle': 'Venner a.p. Advance Video Laryngoscope', 'organization': {'class': 'OTHER', 'fullName': 'International Institute of Rescue Research and Education'}, 'officialTitle': "Intubation of Child and Infant Manikins During Resuscitation. Does the Venner™ A.P. Advance™ Video Laryngoscope Improve Nurses' Performance?", 'orgStudyIdInfo': {'id': 'ETI/2014/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Child ETI withoutchest compressions', 'description': 'Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.', 'interventionNames': ['Device: VAVL', 'Device: MIL']}, {'type': 'EXPERIMENTAL', 'label': 'Child ETI with chest compressions', 'description': 'Endotracheal intubation of mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).', 'interventionNames': ['Device: VAVL', 'Device: MIL']}, {'type': 'EXPERIMENTAL', 'label': 'Infant ETI with chest compressions', 'description': 'endotracheal intubation (ETI) during infant mannikin resuscitation with uninterrupted chest compressions.', 'interventionNames': ['Device: VAVL', 'Device: MIL']}, {'type': 'EXPERIMENTAL', 'label': 'Infant ETI without chest compressions', 'description': 'Endotracheal intubation of infant mannikin during resuscitation without chest compressions.', 'interventionNames': ['Device: VAVL', 'Device: MIL']}], 'interventions': [{'name': 'VAVL', 'type': 'DEVICE', 'otherNames': ['Venner a.p. advance video laryngoscope'], 'description': 'Videolaryngoscope', 'armGroupLabels': ['Child ETI with chest compressions', 'Child ETI withoutchest compressions', 'Infant ETI with chest compressions', 'Infant ETI without chest compressions']}, {'name': 'MIL', 'type': 'DEVICE', 'otherNames': ['Miller Laryngoscope'], 'description': 'Direct laryngoscopy', 'armGroupLabels': ['Child ETI with chest compressions', 'Child ETI withoutchest compressions', 'Infant ETI with chest compressions', 'Infant ETI without chest compressions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03-122', 'city': 'Warsaw', 'state': 'Masovia', 'country': 'Poland', 'facility': 'International Institute of Rescue Research and Education', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Lukasz Szarpak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cardiology, Warsaw, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Institute of Rescue Research and Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lukasz Szarpak', 'investigatorFullName': 'Lukasz Szarpak', 'investigatorAffiliation': 'National Institute of Cardiology, Warsaw, Poland'}}}}