Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-06 @ 1:32 PM
Study NCT ID:
NCT02292693
Status:
UNKNOWN
Last Update Posted:
2014-11-17
First Post:
2014-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Laryngoscopy During Cervical Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-14', 'studyFirstSubmitDate': '2014-11-12', 'studyFirstSubmitQcDate': '2014-11-14', 'lastUpdatePostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of intubation', 'timeFrame': '1 day', 'description': 'effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants'}], 'secondaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': '1 day', 'description': 'time in seconds required for a successful intubation attempt'}, {'measure': 'Cormack-Lehane grading', 'timeFrame': '1 day', 'description': 'self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)'}, {'measure': 'Preferred ETI device', 'timeFrame': '1day', 'description': 'participants were asked which method of ETI they would prefer in a real-life resuscitation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intubation'], 'conditions': ['Trauma']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare time, success rates of different laryngoscope blades for intubation with an immobilized cervical spine in a standardized pediatric manikin model.'}, '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 medicine personnel (physicians, nurses, paramedics)\n\nExclusion Criteria:\n\n* not meet the above criteria\n* wrist or low back diseases'}, 'identificationModule': {'nctId': 'NCT02292693', 'briefTitle': 'Direct Laryngoscopy During Cervical Trauma', 'organization': {'class': 'OTHER', 'fullName': 'International Institute of Rescue Research and Education'}, 'officialTitle': 'Comparison Three Different Laryngoscope Blades for Endotracheal Intubation in Pediatric Patients With Cervical Spine Immobilization.', 'orgStudyIdInfo': {'id': 'ETI/2014/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intubation with immobilized cervical spine', 'description': 'endotracheal intubation with immobilized cervical spine', 'interventionNames': ['Device: MIL', 'Device: MAC', 'Device: McCoy']}], 'interventions': [{'name': 'MIL', 'type': 'DEVICE', 'description': 'Direct laryngoscopy. Laryngoscopy with Miller blade', 'armGroupLabels': ['intubation with immobilized cervical spine']}, {'name': 'MAC', 'type': 'DEVICE', 'description': 'Direct laryngoscopy. Laryngoscopy with Macintosh blade', 'armGroupLabels': ['intubation with immobilized cervical spine']}, {'name': 'McCoy', 'type': 'DEVICE', 'description': 'Direct laryngoscopy. Laryngoscopy with McCoy blade', 'armGroupLabels': ['intubation with immobilized cervical spine']}]}, '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': 'Institute of Cardiology'}]}, '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'}}}}