Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 3:28 PM
Study NCT ID:
NCT01917435
Status:
UNKNOWN
Last Update Posted:
2013-08-06
First Post:
2013-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video-stylet for Nasotracheal Intubation in Limited Mouth Opening Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-04', 'studyFirstSubmitDate': '2013-07-10', 'studyFirstSubmitQcDate': '2013-08-04', 'lastUpdatePostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'perioperative epistaxis, sore throat and hoarseness', 'timeFrame': '2 days', 'description': 'Events of intubating related nasal bleeding are recorded on selected nostril and oral cavity at 3 minutes post-intubation and post-operatively. Incidences of sore throat and hoarseness are evaluated before patients out of recovery room and the following morning'}], 'primaryOutcomes': [{'measure': 'number of the patients with successful nasotracheal intubation and scoring modified intubation difficulty scale', 'timeFrame': 'half an hour', 'description': 'Nasotracheal intubation is assisted by a video-stylet may be performed in patients undergoing Limited Mouth Opening following induction of anesthesia (fentanyl 2 micro-gram/kg, thiamylal 5 mg/kg) and is facilitated by cis-atracurium 0.2 mg/kg administration. propofol 1 mg/kg intravenously to blunt hemodynamic responses while intubation.\n\na modified intubation difficulty scale to evaluate the difficulty of fiber-scope guided or trachway assisted nasotracheal intubation'}], 'secondaryOutcomes': [{'measure': 'time to intubate', 'timeFrame': 'half an hour', 'description': 'time of Intubating the nasotracheal tube (NT) from selected nostril to trachea is continuously calculated but separately into two parts. part one: from leaving off mask ventilation (mask removal from face), to the NT tip on the nasopharynx. part two: advancing NT from nasopharynx, through vocal cord into trachea, to present of 3 end tidal carbon dioxide waveforms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fiberoptic bronchoscopy,', 'Video-stylet,', 'Nasotracheal Intubation'], 'conditions': ['Anesthesia Intubation Complication']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the efficiency of the Video-stylet (Trachway ®) and the fiberoptic bronchoscopy in facilitation of nasotracheal intubation in limited mouth opening patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients with American Society of Anesthesiologists physical status I-III\n2. aged 20-65 years\n3. Requiring Nasotracheal Intubation under general anesthesia\n4. limited mouth open ,mouth open \\< 3 cm\n5. unlimited neck motion\n\nExclusion Criteria:\n\n1. Ankylosing arthritis patients.\n2. BMI≧35 kg/m2'}, 'identificationModule': {'nctId': 'NCT01917435', 'briefTitle': 'Video-stylet for Nasotracheal Intubation in Limited Mouth Opening Patient', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Nasotracheal Intubation Assisted by a Video-stylet in Limited Mouth Opening Patient', 'orgStudyIdInfo': {'id': 'KMUH-IRB-20120254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fiberoptic bronchoscope', 'description': 'Experimental: fiberoptic bronchoscope fiberoptic bronchoscope is used to facilitate for nasotracheal intubation.', 'interventionNames': ['Device: fiberoptic bronchoscope']}, {'type': 'EXPERIMENTAL', 'label': 'video-stylet', 'description': 'Experimental: video-stylet video-stylet is used to facilitate for nasotracheal intubation.', 'interventionNames': ['Device: video-stylet']}], 'interventions': [{'name': 'video-stylet', 'type': 'DEVICE', 'otherNames': ['Device: video-stylet', 'Other Names:', 'The Clarus Video System'], 'armGroupLabels': ['video-stylet']}, {'name': 'fiberoptic bronchoscope', 'type': 'DEVICE', 'otherNames': ['fiberscope'], 'armGroupLabels': ['fiberoptic bronchoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'state': 'Kaohsiung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuang I Cheng, MD, PhD', 'role': 'CONTACT', 'email': 'kuaich@kmu.edu.tw', 'phone': '073121101', 'phoneExt': '7033'}], 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Kuang I Cheng, MD, PhD', 'role': 'CONTACT', 'email': 'kuaich@kmu.edu.tw', 'phone': '073121101', 'phoneExt': '7033'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}