Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-09 @ 7:16 AM
Study NCT ID:
NCT02277405
Status:
UNKNOWN
Last Update Posted:
2014-10-29
First Post:
2014-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Intubation During Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2014-10-27', 'studyFirstSubmitQcDate': '2014-10-27', 'lastUpdatePostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to intubation', 'timeFrame': '1 month', 'description': 'time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.'}], 'secondaryOutcomes': [{'measure': 'Success of intubation', 'timeFrame': '1 month', 'description': 'effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations.'}, {'measure': 'VAS score', 'timeFrame': '1 month', 'description': 'participants were asked which method they would prefer in a real-life resuscitation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intubation', 'Resuscitation']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to compare time and success rates of four intubation devices in a cardiopulmonary scenario with and without chest compressions with a standardized pediatric manikin model.', 'detailedDescription': 'Emergency airway management during resuscitation is a critical skill in emergency medicine. According to the European Resuscitation Council (ERC) guidelines for resuscitation 2010 , endotracheal intubation (ETI) is considered the gold standard during resuscitation.'}, '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 medical personnel (paramedics, nurses, physicians)\n\nExclusion Criteria:\n\n* not meet the above criteria\n* wrist or low back diseases'}, 'identificationModule': {'nctId': 'NCT02277405', 'acronym': 'PIDR', 'briefTitle': 'Pediatric Intubation During Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'International Institute of Rescue Research and Education'}, 'officialTitle': 'A Comparison of Endotracheal Intubation Using the Shikani Optical Stylet or the Endoeye Flexible Intubation During Pediatric Resuscitation', 'orgStudyIdInfo': {'id': 'ETI/2014/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intubation without chest compressions', 'description': 'Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.', 'interventionNames': ['Device: Shikani Optical Stylet', 'Device: Endoeye Flexible Intubation (LF-V)']}, {'type': 'EXPERIMENTAL', 'label': 'Intubation with uninterrupted chest compressions', 'description': 'Endotracheal intubation of pediatric mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).', 'interventionNames': ['Device: Shikani Optical Stylet', 'Device: Endoeye Flexible Intubation (LF-V)']}], 'interventions': [{'name': 'Shikani Optical Stylet', 'type': 'DEVICE', 'description': 'Optical intubation', 'armGroupLabels': ['Intubation with uninterrupted chest compressions', 'Intubation without chest compressions']}, {'name': 'Endoeye Flexible Intubation (LF-V)', 'type': 'DEVICE', 'description': 'endoscopy intubation', 'armGroupLabels': ['Intubation with uninterrupted chest compressions', 'Intubation without chest compressions']}]}, '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': '(+48)500186225'}], 'facility': 'International Institute of Rescue Research and Education', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Lukasz Czyzewski', 'role': 'CONTACT', 'email': 'czyzewski_lukasz@wp.pl', 'phone': '+48696457655'}], 'overallOfficials': [{'name': 'Lukasz Szarpak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cardiology, Warsaw, Poland'}]}, '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'}}}}