Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-03-02 @ 6:17 PM
Study NCT ID:
NCT02295657
Status:
UNKNOWN
Last Update Posted:
2014-11-20
First Post:
2014-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double Lumen Tube Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-18', 'studyFirstSubmitDate': '2014-11-18', 'studyFirstSubmitQcDate': '2014-11-18', 'lastUpdatePostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Endotracheal Intubation', 'Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare time, success rates of different double-lumen tubes in intubation in a standardized 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': 'NCT02295657', 'acronym': 'DLETI', 'briefTitle': 'Double Lumen Tube Intubation', 'organization': {'class': 'OTHER', 'fullName': 'International Institute of Rescue Research and Education'}, 'officialTitle': 'Comparison of Techniques for Double-lumen Tube Intubation: Standard Double-lumen Tube or VivaSight Double Lumen Tube by Paramedics. A Randomized Crossover Manikin Trial.', 'orgStudyIdInfo': {'id': 'ETI/2014/43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ETI intubation', 'description': 'endotracheal intubation in manikin', 'interventionNames': ['Device: standard double-lumen tube', 'Device: VivaSight Double Lumen Tube']}], 'interventions': [{'name': 'standard double-lumen tube', 'type': 'DEVICE', 'description': 'intubation using standard double-lumen tube', 'armGroupLabels': ['ETI intubation']}, {'name': 'VivaSight Double Lumen Tube', 'type': 'DEVICE', 'description': 'intubation using VivaSight Double Lumen Tube', 'armGroupLabels': ['ETI intubation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03-122', 'city': 'Warsaw', 'state': 'Masovia', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Lukasz Szarpak', 'role': 'CONTACT', 'email': 'lukasz.szarpak@gmail.com', 'phone': '+48500186225'}, {'name': 'Lukasz Szarpak', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andrzej Kurowski', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lukasz Czyżewski', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'International Institute of Rescue Research and Education', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Andrzej Kurowski', 'role': 'CONTACT', 'email': 'andrzejkurowski987@gmail.com', 'phone': '+48500186225'}], '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'}}}}