Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT06136858
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cuirass Fitting Study - Time for Mounting and Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'qualitative assessment', 'timeFrame': '15 minuttes', 'description': 'During Cuirass ventilation did you experience discomfort on a scale from 1 to 10, Pain on a scale from 1 to10 And if Cuirass ventilation was the main driver of the partipants ventilation'}], 'primaryOutcomes': [{'measure': 'The primary end point of the study is to evaluate the number of participants who are fitted with the Cuirass shell and have visible ventilation in a two liters breathing bag within three minutes.', 'timeFrame': '15 minuttes', 'description': 'Timing of the above'}], 'secondaryOutcomes': [{'measure': 'Mean time for fitting of the cuirass shell and start of visible ventilation and fraction of participants who can be ventilated within one minute and within two minuttes', 'timeFrame': '15 minuttes', 'description': 'timing of the above'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Airway Disease']}, 'referencesModule': {'references': [{'pmid': '37718095', 'type': 'BACKGROUND', 'citation': 'Kristensen MS, Hesselfeldt R, Schmidt JF. Improvements in cuirass ventilation for airway surgery: origins in Copenhagen on the 70th anniversary of the first intensive care unit. Br J Anaesth. 2023 Oct;131(4):644-648. doi: 10.1016/j.bja.2023.07.021. Epub 2023 Sep 4.'}, {'pmid': '37587006', 'type': 'BACKGROUND', 'citation': 'Kristensen MS, Hesselfeldt R, Schmidt JF. Modern cuirass ventilation for airway surgery: unlimited access to the larynx and trachea in anaesthetised patients. Br J Anaesth. 2023 Oct;131(4):e106-e109. doi: 10.1016/j.bja.2023.07.010. Epub 2023 Aug 14. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Non-invasive biphasic cuirass ventilation (BCV) has recently been described for ENT surgery (ref 1-2). The clinical experience is however still sparse and further study is required.\n\nThe purpose of the study is to descibe 1) mounting time and fitting of the cuirass shell on voluntary participants and 2) time to visible ventilation', 'detailedDescription': 'The purpose of this study is to evaluate the the fitting of the Cuirass shell on healthy volunteers. Even though there is growing knowledge of Cuirass ventilation in anaesthesia, (ref. 1-2) there is sparse experiences with the time required for fitting the Cuirass shell and the time to start of ventilation. This knowledge is paramount before even discussing the potential use of Cuirass ventilation in acute settings in the future.\n\nIn addition to the invitation to the Copenhagen Airway Management course in Copenhagen Denmark on 30th of November 2023, all participants have been invited an has accepted to participate in the study.\n\nIn total 60 to 65 participants will all have the Cuirass shell fitted and will be awake ventilated with Biphasic Cuirass Ventilation. All participants have given consent to being video filmed.\n\nThe study will register the time it takes to fit the Cuirass shell and the time before visible ventilation is obtained.\n\nAll participants will be in their habitual state i.e..no sedation is required since the product was originally designed for home use in awake patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is healthy volunteers, mostly doctors, who participate in a large airway management course i Copenhagen.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants of the airway course\n\nExclusion Criteria:\n\n* Recent surgery in thoracic or abdominal compartments\n* participants with pace-maker'}, 'identificationModule': {'nctId': 'NCT06136858', 'acronym': 'Cuirass', 'briefTitle': 'Cuirass Fitting Study - Time for Mounting and Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Cuirass Shell Fitting and Time to Visible Ventilation in Healthy Volunteers - an Observational Study.', 'orgStudyIdInfo': {'id': 'The Cuirass Fitting Trial'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy volunteers', 'description': 'participants of the Airway management Course in Copenhagen Denmark 2023', 'interventionNames': ['Device: Cuirass ventilation']}], 'interventions': [{'name': 'Cuirass ventilation', 'type': 'DEVICE', 'description': 'We will fit the Cuirass Shell and start Biphasic Cuirass Ventilation on all participants.', 'armGroupLabels': ['healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Oesterbro', 'country': 'Denmark', 'facility': 'Rigshopitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff specialist anaesthesiology MD phD', 'investigatorFullName': 'Jakob Friis Schmidt', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}