Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT07033702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)
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': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility - First-pass success rate of tracheostomy tube exchange using the AEBLScope', 'timeFrame': 'During procedure, at time of intervention', 'description': 'First-pass success defined as successful tracheostomy tube placement on initial attempt using the AEBLScope without need for repeat attempt or alternative instrumentation.'}], 'secondaryOutcomes': [{'measure': 'Feasibility - Procedure duration', 'timeFrame': 'During procedure, at time of intervention', 'description': 'Duration of the airway exchange procedure using the AEBLScope measured in seconds from device insertion to device withdrawal.'}, {'measure': 'Safety - Procedural complications', 'timeFrame': 'During procedure, at time of intervention', 'description': 'Incidence of procedural complications related to use of the AEBLScope including but not limited to bleeding, airway trauma, patient intolerance, etc.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['tracheostomy', 'bronchoscope', 'airway exchange', 'feasibility', 'safety'], 'conditions': ['Tracheotomy Patients', 'Airway Management', 'Airway Disease']}, 'referencesModule': {'references': [{'pmid': '25901542', 'type': 'BACKGROUND', 'citation': 'Roddy DJ, Spaeder MC, Pastor W, Stockwell DC, Klugman D. Unplanned Extubations in Children: Impact on Hospital Cost and Length of Stay. Pediatr Crit Care Med. 2015 Jul;16(6):572-5. doi: 10.1097/PCC.0000000000000406.'}, {'pmid': '15942375', 'type': 'BACKGROUND', 'citation': 'Needham DM, Pronovost PJ. The importance of understanding the costs of critical care and mechanical ventilation. Crit Care Med. 2005 Jun;33(6):1434-5. doi: 10.1097/01.ccm.0000166360.82336.75. No abstract available.'}, {'pmid': '17415123', 'type': 'BACKGROUND', 'citation': 'Tabaee A, Lando T, Rickert S, Stewart MG, Kuhel WI. Practice patterns, safety, and rationale for tracheostomy tube changes: a survey of otolaryngology training programs. Laryngoscope. 2007 Apr;117(4):573-6. doi: 10.1097/MLG.0b013e318030455a.'}, {'pmid': '24257382', 'type': 'BACKGROUND', 'citation': 'McLean S, Lanam CR, Benedict W, Kirkpatrick N, Kheterpal S, Ramachandran SK. Airway exchange failure and complications with the use of the Cook Airway Exchange Catheter(R): a single center cohort study of 1177 patients. Anesth Analg. 2013 Dec;117(6):1325-7. doi: 10.1213/ANE.0b013e3182a7cd3d.'}, {'pmid': '17959966', 'type': 'BACKGROUND', 'citation': 'Mort TC. Continuous airway access for the difficult extubation: the efficacy of the airway exchange catheter. Anesth Analg. 2007 Nov;105(5):1357-62, table of contents. doi: 10.1213/01.ane.0000282826.68646.a1.'}, {'pmid': '26111264', 'type': 'BACKGROUND', 'citation': 'Mort TC, Braffett BH. Conventional Versus Video Laryngoscopy for Tracheal Tube Exchange: Glottic Visualization, Success Rates, Complications, and Rescue Alternatives in the High-Risk Difficult Airway Patient. Anesth Analg. 2015 Aug;121(2):440-8. doi: 10.1213/ANE.0000000000000825.'}, {'pmid': '32310379', 'type': 'BACKGROUND', 'citation': 'Ng J, Hohman MH, Agarwal A. Tracheostomy Tube Change. 2024 Feb 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555919/'}]}, 'descriptionModule': {'briefSummary': 'This pilot study evaluates the safety and feasibility of a novel airway exchange broncholaryngoscope (AEBLScope) during routine tracheostomy tube exchanges in chronically tracheostomy-dependent adult outpatients.', 'detailedDescription': 'The AEBLScope is a modified disposable bronchoscope designed to allow for simultaneous visualization during airway tube exchanges. This prospective, single-arm pilot study will assess the safety, feasibility, and effectiveness of the AEBLScope in low-risk airway tube exchanges.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Chronically (\\>1 month) tracheostomy-dependent outpatients\n* Currently not requiring ventilatory or supplemental oxygen support\n* Have undergone at least one prior tracheostomy tube exchange\n* Scheduled for routine in-office tracheostomy tube exchange\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Active respiratory infection\n* Patients with airway tubes having an inner diameter less than 6.0 mm\n* Patients with preexisting pulmonary conditions, including chronic obstructive pulmonary disease (COPD), restrictive lung disease, untreated pneumonia, or acute respiratory distress syndrome (ARDS)\n* Patients who are tracheostomy-dependent but cannot be orotracheally intubated.\n* Patients unable to provide informed consent and who have no legally authorized representative.'}, 'identificationModule': {'nctId': 'NCT07033702', 'briefTitle': 'Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Pilot Study Assessing the Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope) During Routine Tracheostomy Tube Exchanges', 'orgStudyIdInfo': {'id': '23-06016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chronic Tracheostomy Tube-Dependent Patients', 'description': 'All participants will be be chronically tracheostomy-tube dependent and undergo routine, in-office tracheostomy tube exchanges using the AEBLScope device.', 'interventionNames': ['Device: Airway-Exchange Broncholaryngoscope (AEBLScope)']}], 'interventions': [{'name': 'Airway-Exchange Broncholaryngoscope (AEBLScope)', 'type': 'DEVICE', 'description': 'Airway Exchange Broncholaryngoscope (AEBLScope) - A modified disposable flexible bronchoscope designed to allow visualization during airway tube exchange procedures.', 'armGroupLabels': ['Chronic Tracheostomy Tube-Dependent Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'contacts': [{'name': "Karla O'Dell, M.D.", 'role': 'CONTACT', 'email': 'karla.odell@med.usc.edu', 'phone': '323-422-5790'}, {'name': "Karla O'Dell, M.D.", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Keck Hospital of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Roger Boles, M.D.', 'role': 'CONTACT', 'email': 'roger.boles@med.usc.edu', 'phone': '626-755-3812'}, {'name': 'Roger Boles, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Los Angeles General Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Roger Boles, M.D.', 'role': 'CONTACT', 'email': 'roger.boles@med.usc.edu', 'phone': '626-755-3812'}], 'overallOfficials': [{'name': "Karla O'Dell, M.D.", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univserity of Southern California'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Otolaryngology - Head and Neck Surgery', 'investigatorFullName': "Karla O'Dell", 'investigatorAffiliation': 'University of Southern California'}}}}