Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-26 @ 5:20 AM
Study NCT ID:
NCT03848559
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2019-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Airway Management With Simulated Microgravity Using a Submerged Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058109', 'term': 'Airway Management'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2019-02-19', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of inserts', 'timeFrame': 'after 5 minutes', 'description': 'Summarizing the number of Intubation attempts or attempts to place the supraglottic airway'}, {'measure': 'Time to first ventilation', 'timeFrame': 'after 5 minutes', 'description': 'Time from beginning with the airway manoeuvre (taking the decice) until successful airway secure and first ventilation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Airway Management', 'Emergency Medicine']}, 'descriptionModule': {'briefSummary': 'Trained anesthesiologist- or emergency physician-divers will perform an airway management in simulated microgravity on a submerged model.', 'detailedDescription': 'Trained anesthesiologist- or emergency physician-divers participate in the study. Simulated microgravity during spaceflight is obtained by using a submerged model. Full-torso manikins is going to be used for performing airway management. Each diver attempted airway management with each device (laryngeal mask, laryngeal tube, orotracheal intubation with video-assisted laryngoscope. The time for airway protection will be measured as well as the success rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anaesthesiologist with diver licence or Emergency physician with diver license\n\nExclusion Criteria:\n\n* All other'}, 'identificationModule': {'nctId': 'NCT03848559', 'acronym': 'AirMicroMod', 'briefTitle': 'Airway Management With Simulated Microgravity Using a Submerged Model', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Köln'}, 'officialTitle': 'Airway Management With Simulated Microgravity Using a Submerged Model', 'orgStudyIdInfo': {'id': 'AirMicroMod'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Airway device placement', 'description': 'airway device is placed during the dive', 'interventionNames': ['Device: Airway management with a submerged model']}], 'interventions': [{'name': 'Airway management with a submerged model', 'type': 'DEVICE', 'description': 'Airway management with a submerged manikin using different airway devices in randomized order', 'armGroupLabels': ['Airway device placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Jochen Hinkelbein, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'UK Köln'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Köln', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}