Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT02277951
Status:
COMPLETED
Last Update Posted:
2014-10-29
First Post:
2014-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intubation During Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2014-10-16', 'studyFirstSubmitQcDate': '2014-10-27', 'lastUpdatePostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to successful intubation', 'timeFrame': 'Subjects complete study in 1 day', 'description': "The devices to be compared include (1) The Bonfils Intubation Fibrescope , (2) the Video Rigid Flexing Laryngoscope, (3) the C-MAC® S Video Laryngoscope, (4) the Macintosh Laryngoscope. Successful intubation will be measured in the seconds from insertion of an intubation device to the first manual ventilation of the mannequin's lungs."}, {'measure': 'Success rate of ETI', 'timeFrame': 'Subjects complete study in 1 day', 'description': "The devices to be compared include (1) The Bonfils Intubation Fibrescope , (2) the Video Rigid Flexing Laryngoscope, (3) the C-MAC® S Video Laryngoscope, (4) the Macintosh Laryngoscope. Successful intubation will be measured in the seconds from insertion of an intubation device to the first manual ventilation of the mannequin's lungs."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intubation', 'Cardiopulmonary Resuscitation']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to compare time and success rates of four intubation devices ( in a cardiopulmonary scenario with uninterrupted chest compressions with a standardized manikin model.\n\nThe investigators hypothesized that fiberoscope laryngoscopes may improve success rates.', 'detailedDescription': 'Devices using in study:\n\nThe Bonfils Intubation Fibrescope (BONFILS)(KARL STORZ Endovision, Inc., Charlton, MA, USA), The Video Rigid Flexing Laryngoscope (RIFL)( AI Medical Devices, Inc., Williamston, MI, USA), The C-MAC® S Video Laryngoscope Blade Mac#3(C-MAC®S) (KARL STORZ Endovision, Inc., Charlton, MA, USA) The Macintosh Laryngoscope Blade no. 3 (MAC) (LifeLine Medical, Inc., Brooksville, FL, USA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Personnel of emergency medical services and hospital emergency units', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* experienced emergency personnel: nurses, paramedics\n\nExclusion Criteria:\n\n* no experience in out-of-hospital emergency medicine'}, 'identificationModule': {'nctId': 'NCT02277951', 'acronym': 'IDR', 'briefTitle': 'Intubation During Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'International Institute of Rescue Research and Education'}, 'officialTitle': 'Comparison of Four Types of Laryngoscope for Tracheal Intubation During Chest Compressions', 'orgStudyIdInfo': {'id': 'InternationalIRRE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants', 'description': 'The Bonfils Intubation Fibrescope the Video Rigid Flexing Laryngoscope the C-MAC® S Video Laryngoscope the Macintosh Laryngoscope', 'interventionNames': ['Device: The Bonfils Intubation Fibrescope', 'Device: The Video Rigid Flexing Laryngoscope', 'Device: The C-MAC® S Video Laryngoscope', 'Device: The Macintosh Laryngoscope']}], 'interventions': [{'name': 'The Bonfils Intubation Fibrescope', 'type': 'DEVICE', 'description': 'Effectiveness and time to successful intubation will be measured.', 'armGroupLabels': ['Participants']}, {'name': 'The Video Rigid Flexing Laryngoscope', 'type': 'DEVICE', 'description': 'Effectiveness and time to successful intubation will be measured.', 'armGroupLabels': ['Participants']}, {'name': 'The C-MAC® S Video Laryngoscope', 'type': 'DEVICE', 'description': 'Effectiveness and time to successful intubation will be measured.', 'armGroupLabels': ['Participants']}, {'name': 'The Macintosh Laryngoscope', 'type': 'DEVICE', 'description': 'Effectiveness and time to successful intubation will be measured.', 'armGroupLabels': ['Participants']}]}, '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'}}}}