Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT02090218
Status:
TERMINATED
Last Update Posted:
2024-02-09
First Post:
2014-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
I-Gel in Out-of-hospital Cardiac Arrest in Norway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'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': 'ACTUAL', 'count': 550}}, 'statusModule': {'whyStopped': 'Lack of patients/centres included.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2014-01-29', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ventilation success', 'timeFrame': 'up to 24 hours', 'description': 'ventilation success defined as successful insertion of device with visible chest movement with each ventilation, audible air passage on auscultation, and ETCO2 confirmation (if available) of tube placement'}], 'secondaryOutcomes': [{'measure': 'survival to hospital discharge / 30-day survival', 'timeFrame': 'up to 30 days'}, {'measure': 'levels of ETCO2 related to the presence and quality of bystander CPR', 'timeFrame': 'up to 24 hours'}, {'measure': 'cerebral function assessed by Glascow Outcome Score at discharge from hospital', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'insertion related complications', 'timeFrame': 'up to 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Out of Hospital Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'The main objective of this trial is to compare the effectiveness of a newer supraglottic airway method (the i-Gel), compared to current airway management practice in out-of-hospital cardiac arrests treated by Norwegian ambulance services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Out-of-hospital cardiac arrest patients requiring and receiving advanced airway management on ambulance missions. Advanced airway management is defined as the attempted insertion of an airway adjunct (I-Gel, laryngeal tube or ETI) or the administration of ventilatory assistance/support (including bag-mask ventilation (BMV) or other ventilatory support.\n* Adult patients (\\> 18 years).\n\nExclusion Criteria:\n\n* Non-adult patients / minors (\\< 18 years).\n* Traumatic cardiac arrest.'}, 'identificationModule': {'nctId': 'NCT02090218', 'acronym': 'I-CAN', 'briefTitle': 'I-Gel in Out-of-hospital Cardiac Arrest in Norway', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'I-Gel Versus Current Practice in Out-of-hospital Cardiac Arrest by Paramedics in Norway - a Prospective Stepped Wedge Crossover Trial', 'orgStudyIdInfo': {'id': '2013/984/REK-Vest.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'I-Gel', 'description': 'I-Gel supraglottic airway device', 'interventionNames': ['Device: I-Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LTS, ETI or other airway practice', 'description': 'Laryngeal tube, endotracheal tube or other current airway management practice', 'interventionNames': ['Device: LTS, ETI or current airway management practice']}], 'interventions': [{'name': 'I-Gel', 'type': 'DEVICE', 'description': 'I-Gel supraglottic airway device', 'armGroupLabels': ['I-Gel']}, {'name': 'LTS, ETI or current airway management practice', 'type': 'DEVICE', 'description': 'Laryngeal tube, endotracheal tube, bag-mask-ventilation', 'armGroupLabels': ['LTS, ETI or other airway practice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '2381', 'city': 'Brumunddal', 'country': 'Norway', 'facility': 'Innlandet Sykehus HF', 'geoPoint': {'lat': 60.88095, 'lon': 10.93948}}, {'zip': '5504', 'city': 'Haugesund', 'country': 'Norway', 'facility': 'Helse Fonna HF', 'geoPoint': {'lat': 59.41378, 'lon': 5.268}}, {'zip': '7502', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Ambulanse Midt-Norge HF', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Geir A Sunde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haukeland University Hospital'}, {'name': 'Jon-Kenneth Heltne, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Haukeland University Hospital'}, {'name': 'Guttorm Brattebø, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Haukeland University Hospital'}, {'name': 'Hanne Klausen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Haukeland University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sykehuset Innlandet HF', 'class': 'OTHER'}, {'name': 'Helse Midt-Norge', 'class': 'OTHER'}, {'name': 'Helse Fonna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}