Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-07 @ 4:14 AM
Study NCT ID:
NCT03238950
Status:
WITHDRAWN
Last Update Posted:
2019-08-14
First Post:
2017-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cricothyroidotomy Training for Physicians Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000402', 'term': 'Airway Obstruction'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This study has never actually started as waiting on funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2017-08-01', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to successfully complete surgical cricothyroidotomy on a prepared porcine specimen.', 'timeFrame': '1 day', 'description': 'time'}], 'secondaryOutcomes': [{'measure': 'Success rate for cricothyroidotomy', 'timeFrame': '1 day', 'description': 'subjective reporting of confidence through questionnaire'}, {'measure': 'Complication rate for cricothyroidotomy', 'timeFrame': '1 day', 'description': 'subjective reporting of confidence through questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Airway Obstruction']}, 'descriptionModule': {'briefSummary': 'This study will assess whether the type of simulation model used in cricothyroidotomy training has an effect on the subsequent confidence and competence in the procedure.', 'detailedDescription': 'This is a Pilot study - prospective randomised controlled trial involving:\n\n1. Assessment of ability to complete a surgical cricothyroidotomy\n2. Completion of questionnaire prior to training and prior to assessment\n\nPrior to beginning training, questionnaires will be completed by all participants asking their level of previous training. Current confidence level for completion of cricothyroidotomy will be marked on a visual analogue scale (VAS).\n\nTraining will then be completed with each group using the appropriate manikin type - porcine or synthetic. This will consist of didactic information on the procedure delivered via recorded information to standardise this initial training, and then proceeding to supervised practice of the procedure for two occasions. This will be completed by the same trainer, with the same information given to both groups. Questions to clarify how to perform the procedure will be permitted.\n\nThe second questionnaire will be given to the trainees on completion of training to mark on a visual analogue scale their confidence level at this point.\n\nAssessment will then be completed later the day comprising of assessment of completion of surgical cricothyroidotomy using a porcine manikin with skin overlying. This will be different to the porcine manikin used for training. The assessment will time the trainees from start to completion of airway insertion, as well as a checklist of activities to be achieved. The porcine manikins will then be dissected to identify if correct location for insertion was achieved and complications. The same amount of time will be given between groups training and assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically trained healthcare professionals working in Anaesthetics, Emergency Medicine or General Surgery as these doctors may be expected to complete a surgical cricothyroidotomy despite infrequently performing the procedure.\n* The healthcare professionals can be from Foundation Year 1 to before Certificates of Completion of Training (CCT). Those who are out of training and are not yet at consultant level are also eligible.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n• Healthcare professionals who already complete surgical airways on a regular basis (e.g. Ear Nose Throat or Maxillofacial trainees) as these doctors may already be competent prior to training.'}, 'identificationModule': {'nctId': 'NCT03238950', 'briefTitle': 'Cricothyroidotomy Training for Physicians Outcomes Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The Royal Wolverhampton Hospitals NHS Trust'}, 'officialTitle': 'In Cricothyroidotomy Training for Physicians Does Simulated Practice With Tissue Specimens Produce Better Outcomes Than Using Synthetics Manikins?', 'orgStudyIdInfo': {'id': '2017SUR96'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Porcine Group', 'description': 'Training conducted on Porcine model', 'interventionNames': ['Other: Porcine model']}, {'type': 'OTHER', 'label': 'Synthetic', 'description': 'Training conducted on synthetic model', 'interventionNames': ['Other: Synthetic model']}], 'interventions': [{'name': 'Porcine model', 'type': 'OTHER', 'description': 'participants to conduct training on porcine model', 'armGroupLabels': ['Porcine Group']}, {'name': 'Synthetic model', 'type': 'OTHER', 'description': 'participants to conduct training on synthetic model', 'armGroupLabels': ['Synthetic']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'The Royal Wolverhampton NHS Trust', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'overallOfficials': [{'name': 'Michael Helme', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Royal Wolverhampton NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Royal Wolverhampton Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}