Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-22 @ 12:07 PM
Study NCT ID:
NCT02289651
Status:
UNKNOWN
Last Update Posted:
2014-11-13
First Post:
2014-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Pediatric 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': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-12', 'studyFirstSubmitDate': '2014-11-10', 'studyFirstSubmitQcDate': '2014-11-12', 'lastUpdatePostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of intubation', 'timeFrame': '1 MONTH', 'description': 'effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants'}], 'secondaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': '1 MONTH', 'description': 'time in seconds required for a successful intubation attempt'}, {'measure': 'POGO score', 'timeFrame': '1 MONTH', 'description': 'self-reported percentage of glottis opening (POGO) score'}, {'measure': 'Cormack-Lehane grading', 'timeFrame': '1 MONTH', 'description': 'self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intubation'], 'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'We hypothesized that the Venner videolaryngoscope (A.P. Advance™) is beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of the Venner videolaryngoscope (A.P. Advance™) and MIL laryngoscopes in child resuscitation with and without CC.'}, '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 nursing\n\nExclusion Criteria:\n\n* Not meet the above criteria\n* Wrist or Low back diseases'}, 'identificationModule': {'nctId': 'NCT02289651', 'acronym': 'PETI', 'briefTitle': 'Effectiveness of Pediatric Intubation', 'organization': {'class': 'OTHER', 'fullName': 'International Institute of Rescue Research and Education'}, 'officialTitle': 'Comparison of the Venner(TM) A.P. Advance(TM) With the Macintosh Laryngoscope for Emergency Intubation in a Standardized Airway Manikin With and Without Chest Compressions by Nurses. A Randomized, Controlled Crossover Trial.', 'orgStudyIdInfo': {'id': 'ETI/2014/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intubation without chest compressions', 'description': 'Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.', 'interventionNames': ['Device: Venner', 'Device: Miller']}, {'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: Venner', 'Device: Miller']}], 'interventions': [{'name': 'Venner', 'type': 'DEVICE', 'otherNames': ['The Venner A.P. Advance Video Laryngoscope'], 'description': 'Video-laryngoscopy', 'armGroupLabels': ['Intubation with uninterrupted chest compressions', 'Intubation without chest compressions']}, {'name': 'Miller', 'type': 'DEVICE', 'otherNames': ['Miller Laryngoscope'], 'description': 'Direct-Laryngoscopy', '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': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andrzej Kurowski, PhD, MD', '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'}}}}