Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-03 @ 6:29 AM
Study NCT ID:
NCT02804451
Status:
COMPLETED
Last Update Posted:
2016-06-17
First Post:
2016-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intubation During Cardiopulmonary Resuscitation
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': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-14', 'studyFirstSubmitDate': '2016-06-11', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to the first ventilation attempt', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'time to visualize the larynx', 'timeFrame': '1 day'}, {'measure': 'time to introduce the endotracheal tube through the vocal cords', 'timeFrame': '1 day'}, {'measure': 'success rate', 'timeFrame': '1 day', 'description': 'first intubation attempt success rate'}, {'measure': 'degree of larynx visibility', 'timeFrame': '1 day', 'description': 'analysed based on a Cormack-Lehane scale'}, {'measure': 'ease of intubation technique', 'timeFrame': '1 day', 'description': '10-point visual analogue scale (VAS) was used, where 1 indicated an extremely simple procedure, while 10 - an extremely difficult one'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Endotracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '26020389', 'type': 'BACKGROUND', 'citation': 'Kurowski A, Szarpak L, Truszewski Z, Czyzewski L. Can the ETView VivaSight SL Rival Conventional Intubation Using the Macintosh Laryngoscope During Adult Resuscitation by Novice Physicians?: A Randomized Crossover Manikin Study. Medicine (Baltimore). 2015 May;94(21):e850. doi: 10.1097/MD.0000000000000850.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to compare the intubation time and effectiveness, the grade of larynx visibility, and the ease of intubation in adults performed by nurses using 4 devices: a Macintosh blade laryngoscope (MAC), and a TruView EVO2 (EVO2), TruView EVO2 PCD (PCD), and ETView SL (ETView) laryngoscope, in simulated CPR settings with and without CC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* had not received any training in endotracheal intubation with videolaryngoscopy before the study,\n* had nursing specialization in anaesthesiology or emergency medicine,\n* presented with no wrist or low back diseases or pregnancy.\n\nExclusion Criteria:\n\n* not meet the above criteria.'}, 'identificationModule': {'nctId': 'NCT02804451', 'briefTitle': 'Intubation During Cardiopulmonary Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'orgStudyIdInfo': {'id': '03/02/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intubation without chest compression', 'description': 'normal airway, without chest compression during intubation.', 'interventionNames': ['Device: Macintosh laryngoscope', 'Device: TruView EVO2 laryngoscope', 'Device: TruView EVO2 PCD laryngoscope', 'Device: ETView SL']}, {'type': 'EXPERIMENTAL', 'label': 'Intubation with uninterrupted chest compression', 'description': 'normal airway, with continuous chest compressions', 'interventionNames': ['Device: Macintosh laryngoscope', 'Device: TruView EVO2 laryngoscope', 'Device: TruView EVO2 PCD laryngoscope', 'Device: ETView SL']}], 'interventions': [{'name': 'Macintosh laryngoscope', 'type': 'DEVICE', 'otherNames': ['MAC'], 'description': 'intubation with standard macintosh larygoscope; gold standard', 'armGroupLabels': ['Intubation with uninterrupted chest compression', 'Intubation without chest compression']}, {'name': 'TruView EVO2 laryngoscope', 'type': 'DEVICE', 'otherNames': ['EVO2'], 'description': 'A TruView EVO2 laryngoscope with blade size 3 (EVO2; Truphatek Holdings, Ltd., Netanya, Israel),', 'armGroupLabels': ['Intubation with uninterrupted chest compression', 'Intubation without chest compression']}, {'name': 'TruView EVO2 PCD laryngoscope', 'type': 'DEVICE', 'otherNames': ['PCD'], 'description': 'A TruView EVO2 PCD laryngoscope with blade size 3 (PCD; Truphatek Interbational Ltd., Netanya, Israel),', 'armGroupLabels': ['Intubation with uninterrupted chest compression', 'Intubation without chest compression']}, {'name': 'ETView SL', 'type': 'DEVICE', 'otherNames': ['ETView'], 'description': 'An ETView SL (ETView; ETViewLtd, Misgav, Israel) ednotracheal tube', 'armGroupLabels': ['Intubation with uninterrupted chest compression', 'Intubation without chest compression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-005', 'city': 'Warsaw', 'state': 'Masovia', 'country': 'Poland', 'facility': 'Medical University of Warsaw, Department of Emergency Medicine', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Lukasz Szarpak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Łukasz Szarpak', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}