Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 3:34 AM
Study NCT ID:
NCT04005950
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2019-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of a Conventional and a Realistic Self-modified Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-21', 'studyFirstSubmitDate': '2019-06-30', 'studyFirstSubmitQcDate': '2019-06-30', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of trials', 'timeFrame': 'up to 12 minutes'}], 'primaryOutcomes': [{'measure': 'evaluation of realistic applicability', 'timeFrame': '12 minutes', 'description': 'using Likert scale (1=very realistic, 2= realistic, 3= not very realistic, 4=unrealistic)'}], 'secondaryOutcomes': [{'measure': 'Time from initial handling equipment to a successful placement of the tracheal cannula', 'timeFrame': '300 seconds'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cricothyroidotomy', 'Difficult Airway', 'Obesity']}, 'descriptionModule': {'briefSummary': 'According to the recently published german guidelines for the prehospital airway management regular training for cricothyroidotomy is recommended.\n\nEven though participants prefer animal or cadaver trainingmodels, it is not possible to perform this comprehensive for a large number of participants due to organizational requirements like food hygiene, limited shelf-life and preparation time and expense.\n\nTherefore the investigators modified an available for purchase cricothyroidotomy trainer (the AirSim Combo X) with everyday suitable and cost-effective utensils.\n\nAs a control group the investigators used a conventional simple plastic model.', 'detailedDescription': 'Obesity is an important risk factor for a cannot intubate cannot ventilate situation. Obese patients are more likely to require a cricothyroidotomy, due to failure rates of routine airway management. Relevant landmarks can be difficult to palpate. And the greater depth of the soft tissues overlying the larynx. Due to this reasons the investigators modified the adult intubation manikin AirSim Combo X with a drunk baby diaper to simulate the neck of an obese patient.\n\nAs a further modification the investigators prepared freezer bags filled with faked blood to simulate a possible bleeding.\n\n35 medial doctors of the department of anesthesiology and 35 paramedics are going to perform two cricothyroidotomies in each model.\n\nFor the one time participants use the ScalpelCric Set and for the other time participants use the ScalpelCric Set plus a speculum.\n\nPrimary endpoint is the evaluation of reality of the two different manikins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'medical doctors of the Department of anesthesiology of the University hospital Mainz, Germany', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* german language in speaking and writing\n* capability of giving consent\n\nExclusion Criteria:\n\n* participants unwilling or unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT04005950', 'briefTitle': 'Comparison of a Conventional and a Realistic Self-modified Model', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Evaluation and Comparison of a Modified Skalpell-Bougie-technique for Cricothyreotomie: Comparison of a Conventional and a Realistic Self-modified Model', 'orgStudyIdInfo': {'id': 'ScalpelCric Advanced'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'medical doctors', 'interventionNames': ['Device: Scalpel Bougie technique', 'Device: modified Scalpel Bougie technique']}, {'label': 'paramedics', 'interventionNames': ['Device: Scalpel Bougie technique', 'Device: modified Scalpel Bougie technique']}], 'interventions': [{'name': 'Scalpel Bougie technique', 'type': 'DEVICE', 'description': 'ScalpelCric Set', 'armGroupLabels': ['medical doctors', 'paramedics']}, {'name': 'modified Scalpel Bougie technique', 'type': 'DEVICE', 'description': 'ScalpelCric Set plus speculum', 'armGroupLabels': ['medical doctors', 'paramedics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Johannes Gutenberg - Universität', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Nina Pirlich, Dr. med.', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}