Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-01-04 @ 8:21 AM
Study NCT ID:
NCT04735250
Status:
UNKNOWN
Last Update Posted:
2021-02-03
First Post:
2021-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a Properly Video Stylet Angulation for Orotracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '* undergoing surgery with general anesthesia(GA)\n* ASA(American Society of Anesthesiologists):Ι to III\n* 20 to 65 years old\n* mouth open \\> 3cm\n* the systemic disease exclusion/conscious clear and without major Neurocognitive Disorder'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-31', 'studyFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2021-01-31', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success rate of video stylet angulation and successful first tube attempt in 60 seconds', 'timeFrame': 'During procedure', 'description': 'successful rate of the properly video stylet angulation passing through oral cavity into trachea.\n\nTime: TTI(time taken advancement) is less than 60 seconds in first tube attempt, it defines successful; TTI(time taken advancement) is over 60 seconds in first tube attempt, it defines unsuccessful.'}, {'measure': "success rate of video stylet angulation and successful first tube attempt in Lung's ventilation", 'timeFrame': 'During procedure', 'description': "successful rate of the properly video stylet angulation passing through oral cavity into trachea.\n\nLung's ventilation: The lung's ventilation is success."}, {'measure': 'time taken advancement(TTI)', 'timeFrame': 'During procedure', 'description': 'time taken advancement from oral cavity into trachea in each time interval'}, {'measure': 'assessment of difficult intubation(IDS)', 'timeFrame': 'During procedure', 'description': 'Assessment of difficult intubation by Intubation Difficulty Scale(The Intubation Difficulty Scale, IDS, 1997) is required after intubation. Number of Attempts\\>1, score "N1"; Number of Operators \\>1, score "N2"; Number of Alternative Techniques, score "N3"; Comark Grade -1, score "N4"; Lifting Force Required Normal, score "N5=0"; Lifting Force Required Increased, score "N5=1"; Laryngeal Pressure Not applied, score "N6=0"; Laryngeal Pressure Applied, score "N6=1"; Vocal Cord Mobility Abducion, score "N7=0"; Vocal Cord Mobility Adducion, score "N7=1". IDS=Sum of scores(N1-N7). If IDS score gains "0" means "Easy", "0\\<IDS≤5" means "Slight Difficulty", "5\\<IDS" means "Moderate to Major Difficulty", "IDS=∞" means "Impossible intubation".'}, {'measure': 'assessment of Glottic grade(Cormack Grade)', 'timeFrame': 'During procedure', 'description': 'Assessment of Glottic grade(Cormack Grade) is required after intubation. The definitions of grade: Grade 1: full view of the glottis; Grade 2a: partial view of the glottis; Grade 2b: arytenoids only; Grade 3: epiglottis only; Grade 4: neither glottis or epiglottis identified'}], 'secondaryOutcomes': [{'measure': 'post-intubation induced oropharyngeal bleeding, hoarseness and sore throat', 'timeFrame': 'Day 2(the day after the operation)', 'description': 'A visiting questionnaire is used to measure the condition of post-intubation, including oropharyngeal bleeding, sore throat, hoarseness, dysphagia. The score for the measurement of oropharyngeal bleeding, sore throat, hoarseness, dysphagia is divided into four degrees: none, mild, moderate and severe. All the evaluation will be assessed in the next coming morning after the postoperation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['video stylet', 'angulation', 'orotracheal Intubation', 'trachway', 'tracheal intubation', 'Endotracheal Tube intubation General Anesthesia (ETGA)'], 'conditions': ['Intubation Complication']}, 'descriptionModule': {'briefSummary': 'Uses the video stylet with different angulation to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea', 'detailedDescription': 'In the patients receiving general anesthesia with nasotracheal or orotracheal intubation is common. However, a orotracheal tube blindly passing through the oral cavity and oropharynx may easily result in oral cavity and oropharynx damages.\n\nThe advancement of the tube from oropharynx into trachea may assist using the video stylet.\n\nThe aim of the study is to investigate use which angulation including 45 degree, 70 degree and 90 degree is appropriate to assist the orotracheal tube passing the oral cavity, oropharynx, and advanced into the trachea.\n\nPatients are randomized into three groups by 45 degree, 70 degree and 90 degree to facilitate orotracheal tube sliding through into trachea and compared with each other group. Hemodynamic changes in each time interval, each time taken of tube going through the oral cavity, tube advanced from oropharynx into trachea will be recorded.\n\nThe incidence of using the video stylet with different angulation to accurately place tube tip into trachea, intubation related side effects and complications are recorded at postoperative time stages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult(20 to 65 years old)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing surgery with general anesthesia(GA)\n* ASA(American Society of Anesthesiologists):Ι to III\n* 20 to 65 years old\n* mouth Open \\> 3 cm\n* the systemic disease exclusion\n* conscious clear and without major Neurocognitive Disorder\n* Mandarin or Taiwanese speaker\n* agree the purpose of the study and sign the ICF\n\nExclusion Criteria:\n\n* difficult airway assessment \\[limited mouth opening \\< 3cm, limited neck motion(thyromental distance \\< 6cm)\\]\n* previous head neck surgery history, oral and respiratory tract tumors, oral infections, neck disease, loosen tooth\n* morbid obesity\n* reject to participate'}, 'identificationModule': {'nctId': 'NCT04735250', 'briefTitle': 'Assessment of a Properly Video Stylet Angulation for Orotracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Assessment of a Properly Video Stylet Angulation for Orotracheal Intubation', 'orgStudyIdInfo': {'id': 'KMUHIRB-F(II)-20200132'}}, 'armsInterventionsModule': {'armGroups': [{'label': '45° group', 'description': 'Uses the video stylet with 45 degree(The tip of the trachway in 45°-55°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea'}, {'label': '70° group', 'description': 'Uses the video stylet with 70 degree(The tip of the trachway in 60°-70°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea'}, {'label': '90° group', 'description': 'Uses the video stylet with 90 degree(The tip of the trachway in 80°-90°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea'}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'state': 'Sanmin District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chia-Heng Lin, MD', 'role': 'CONTACT', 'email': 'linsofar@yahoo.com.tw', 'phone': '88673121101', 'phoneExt': '7035'}], 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Chia-Heng Lin, MD', 'role': 'CONTACT', 'email': 'linsofar@yahoo.com.tw', 'phone': '88673121101', 'phoneExt': '7035'}, {'name': 'Kuang-I Cheng, MD, PhD', 'role': 'CONTACT', 'email': 'kuaich@kmu.edu.tw', 'phone': '88673121101', 'phoneExt': '7035'}], 'overallOfficials': [{'name': 'Chia-Heng Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Chia-Heng Lin, MD', 'investigatorAffiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}}}}