Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT04564105
Status:
COMPLETED
Last Update Posted:
2023-03-15
First Post:
2020-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Simulation Training and Teamwork Concerning Intubation on the Icu
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2020-09-14', 'studyFirstSubmitQcDate': '2020-09-18', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation between technical and non-technical skills', 'timeFrame': '2 years', 'description': 'Investigators will study if technical and non-technical skills assessed with appropriate measurement tool like ANTS and JIT-PAPPS will correlate before and after simulation education'}, {'measure': 'correlation of group performance between simulation and real-life intubations', 'timeFrame': '2 years', 'description': 'Investigators will study if technical and non-technical skills assessed with appropriate measurement tool like ANTS and JIT-PAPPS will correlate between simulation intubations and real-life intubations adjusted for experience of the group'}], 'secondaryOutcomes': [{'measure': 'change of the group performance', 'timeFrame': '2 years', 'description': 'Investigators will study if technical and non-technical skills assessed with appropriate measurement tool like ANTS and JIT-PAPPS will change after the simulation intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intubation', 'simulation', 'airway management', 'education', 'video-record', 'checklist'], 'conditions': ['Airway Management']}, 'descriptionModule': {'briefSummary': 'To assess effects of the simulation education on the group intubating patients in the iCU, in this prospective study investigators will video-record real-life intubations and simulations. From videos will be assessed correlation of technical and non-technical skills before and after the education and performance in real-life vs simulation intubation.', 'detailedDescription': "The aim of this trial is to study the effects of simulation education on the action of the group managing patient's airway in the intensive care unit (ICU). Before simulations investigators will video-record 20 real-world intubations. Consequently will be run simulations to whole staff of the ICU. After the education further 20 real-world intubations will be recorded. Also simulations are recorded. From the videos investigators assess technical and non-technical skills of the group before and after simulation education, correlations between groups and influence of the education on action of the group. On the first part of the study, hypothesis is that group's good non-technical skills improve also technical skills. On the second part of the study hypothesis is that performing well in simulation correlates with performing well in real-world situation and teams with less experience the correlation is stronger."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n-intubations in the icu operated by staff who have given informed consent to this study\n\nExclusion Criteria:\n\n* intubations in the icu operated by anybody who have rejected video-recording\n* intubations in the icu, when patient or patient being unable, close relative has denied permission to use video in this study\n* intubated patient is a child, a prisoner, under military service, under forensic psychiatric evaluation, or patient can't give informed consent for example because of the cognitive impairment\n* patient is isolated"}, 'identificationModule': {'nctId': 'NCT04564105', 'briefTitle': 'Simulation Training and Teamwork Concerning Intubation on the Icu', 'organization': {'class': 'OTHER', 'fullName': 'Joint Authority for Päijät-Häme Social and Health Care'}, 'officialTitle': "The Influence of Simulation Education on Action of the Group Managing Patient's Airway on the ICU", 'orgStudyIdInfo': {'id': '0151/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Staff of the ICU', 'description': "The whole staff (nurses and doctors) of the ICU will be recruited to this trial. When they give their informed consent, video-recording of the intubations will be started. After 20 videos, simulations will be run. Also simulations will be recorded. Thereafter 20 further real-life intubations will be recorded. Staff intubating patients before and after won't be same but they will be adjusted for experience related to intubations.", 'interventionNames': ['Behavioral: simulation education']}], 'interventions': [{'name': 'simulation education', 'type': 'BEHAVIORAL', 'description': 'Intubation protocol will be trained by simulation exercise.', 'armGroupLabels': ['Staff of the ICU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15850', 'city': 'Lahti', 'country': 'Finland', 'facility': 'PaijatHame Central Hospital', 'geoPoint': {'lat': 60.98267, 'lon': 25.66151}}], 'overallOfficials': [{'name': 'Miretta Tommila', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Turku'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'from now on till 10 years after study', 'ipdSharing': 'YES', 'description': 'available on reasonable request excluded videos'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joint Authority for Päijät-Häme Social and Health Care', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Turku', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}