Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 2:19 AM
Study NCT ID:
NCT05899868
Status:
COMPLETED
Last Update Posted:
2024-12-05
First Post:
2023-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utilization of Airway Stabilizing Rod
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', 'interventionModelDescription': 'Testing of device for success during endotracheal intubation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2023-05-16', 'studyFirstSubmitQcDate': '2023-06-02', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall time in the airway', 'timeFrame': '5 minutes', 'description': 'Time from fiberoptic placement onto airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.'}, {'measure': 'Total time to intubation', 'timeFrame': '3 minutes', 'description': 'Time from movement of the device to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Airway Complication of Anesthesia']}, 'referencesModule': {'references': [{'pmid': '39774053', 'type': 'DERIVED', 'citation': 'Adler AC, Duong K, Chandrakantan A. Fiberoptic-Assisted Endotracheal Rod for Endotracheal Intubation Through a Supraglottic Airway in Patients with Difficult Intubation: A Clinical Device Study. Anesth Analg. 2025 Apr 1;140(4):986-989. doi: 10.1213/ANE.0000000000007268. Epub 2024 Nov 21. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The pediatric airway is known to be more challenging than the adult airway when performing endotracheal intubation. When a patient cannot be ventilated and/or intubated, the guidelines for airway management dictate that a laryngeal mask airway (LMA) be used as a rescue device to oxygenate and ventilate the patient. While an excellent device the LMA is seen as temporary and ultimately needs to be replaced by an endotracheal tube (ETT).', 'detailedDescription': 'The objective is to study this device in patients with difficult airway to assess the success rate and time to intubation for placing an endotracheal tube using this device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 5-18 years\n* Requiring intubation\n* Known difficult airway\n* LMA placement possible\n\nExclusion Criteria:\n\n* Known normal airway\n* Procedure not requiring endotracheal intubation\n* Parental refusal\n* Patient dissent'}, 'identificationModule': {'nctId': 'NCT05899868', 'acronym': 'FASTER', 'briefTitle': 'Utilization of Airway Stabilizing Rod', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Utilization of Airway Stabilizing Rod to Assist With LMA Guided Fiberoptic Intubation in Children', 'orgStudyIdInfo': {'id': 'H50120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Time to intubation using FASTER device', 'description': 'Time from fiberoptic placement into airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.', 'interventionNames': ['Device: Time to Intubation using FASTER device']}], 'interventions': [{'name': 'Time to Intubation using FASTER device', 'type': 'DEVICE', 'otherNames': ['FASTER'], 'description': 'Time from fiberoptic placement onto airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.', 'armGroupLabels': ['Time to intubation using FASTER device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hosppital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Arvind Chandrakantan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This pilot data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology', 'investigatorFullName': 'Arvind Chandrakantan', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}