Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-25 @ 4:37 PM
Study NCT ID:
NCT02681835
Status:
COMPLETED
Last Update Posted:
2016-03-09
First Post:
2016-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endotracheal Intubation in Prehospital Scenario
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': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-08', 'studyFirstSubmitDate': '2016-02-10', 'studyFirstSubmitQcDate': '2016-02-11', 'lastUpdatePostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time required for successful intubation', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'success rate of intubation attempt', 'timeFrame': '1 day', 'description': 'success rate of first, second and third intubation attempt'}, {'measure': 'cumulative success ratios related to time', 'timeFrame': '1 day', 'description': 'cumulative success ratio was counted as percentage of successful intubations in time intervals in all scenarios'}, {'measure': 'Ease of intubation', 'timeFrame': '1 day', 'description': 'To access subjective opinion about the difficulty of each intubation method, participants were asked to rate it on a visual analog scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).'}, {'measure': 'Cormack&Lehane grade', 'timeFrame': '1 day', 'description': 'glottic view during intubation rate using Cormack\\&Lehane grade'}, {'measure': 'Dental Compression', 'timeFrame': '1 day', 'description': 'the severity of the potential dental trauma was calculated based on previously described modified grading scale (Svoldelli, 2009)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Endotracheal Intubation']}, 'descriptionModule': {'briefSummary': 'We therefore designed this randomized crossover study to compare C-MAC with Macintosh laryngoscope in emergency intubation performed by paramedics according to three different intubator positions.'}, '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* maximum 1 year of work experience in medicine\n* minimum 50 clinical intubations\n* paramedics\n\nExclusion Criteria:\n\n* not meet the above criteria\n* wrist or low back diseases'}, 'identificationModule': {'nctId': 'NCT02681835', 'briefTitle': 'Endotracheal Intubation in Prehospital Scenario', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Comparison of the C-MAC and Macintosh Laryngoscopes for Tracheal Intubation in Different Intubator Positions. A Randomized, Crossover, Manikin Trial', 'orgStudyIdInfo': {'id': '02.007.1MR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Position 1', 'description': 'Standard position during intubation. Intubator is behind head of the victim, propped up on both elbows', 'interventionNames': ['Device: C-MAC laryngoscope', 'Device: Macintosh laryngoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Position 2', 'description': 'Intubator is behind head of the victim, lies on the left side', 'interventionNames': ['Device: C-MAC laryngoscope', 'Device: Macintosh laryngoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Position 3', 'description': 'Intubator stands astride the victims, intubated using the face-to-face', 'interventionNames': ['Device: C-MAC laryngoscope', 'Device: Macintosh laryngoscope']}], 'interventions': [{'name': 'C-MAC laryngoscope', 'type': 'DEVICE', 'otherNames': ['C-MAC'], 'description': 'Intubation performed using C-MAC laryngoscope', 'armGroupLabels': ['Position 1', 'Position 2', 'Position 3']}, {'name': 'Macintosh laryngoscope', 'type': 'DEVICE', 'otherNames': ['C-MAC'], 'description': 'Intubation performed using laryngoscope with Macintosh blade', 'armGroupLabels': ['Position 1', 'Position 2', 'Position 3']}]}, '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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Łukasz Szarpak', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}