Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT06709118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-29
First Post:
2024-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Different Fiberoptic Outer Diameters on Fiberoptic Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055100', 'term': 'Optical Fibers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-11-27', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fiberoptic intubation attempts', 'timeFrame': 'during the procedure', 'description': 'This is used to observe the passage of the tracheal tube through the glottis'}, {'measure': 'First intubation success rate', 'timeFrame': 'during the procedure', 'description': 'The incidence of tracheal tube through the vocal cords'}, {'measure': 'Fiberoptic intubation time', 'timeFrame': 'during the procedure', 'description': 'The duration of the intubation process'}, {'measure': 'Time of passage of tracheal intubation through glottis', 'timeFrame': 'during the procedure', 'description': 'The time the tracheal tube enters the trachea'}], 'secondaryOutcomes': [{'measure': 'Hoarseness after surgery', 'timeFrame': '24 hours after surgery', 'description': 'Patients were asked about voice changes 24 hours after surgery'}, {'measure': 'Sore throat', 'timeFrame': '24 hours after surgery', 'description': 'Patients were asked about throat pain 24 hours after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intubation', 'Ffiberoptic', 'Perioperative', 'Sore throat', 'Success rate'], 'conditions': ['Intubation Times']}, 'referencesModule': {'references': [{'pmid': '29028928', 'type': 'BACKGROUND', 'citation': 'Piegeler T, Clausen NG, Weiss M. Effectiveness of tip rotation in fibreoptic bronchoscopy under different experimental conditions: an in vitro crossover study. Br J Anaesth. 2017 Dec 1;119(6):1206-1212. doi: 10.1093/bja/aex322.'}, {'pmid': '32415788', 'type': 'BACKGROUND', 'citation': 'Karmali S, Rose P. Tracheal tube size in adults undergoing elective surgery - a narrative review. Anaesthesia. 2020 Nov;75(11):1529-1539. doi: 10.1111/anae.15041. Epub 2020 May 16.'}, {'pmid': '36469051', 'type': 'BACKGROUND', 'citation': 'Teulieres M, Berard E, Marot V, Reina N, Ferre F, Minville V, Cavaignac E. A quadruple peripheral nerve block outside the OR for anterior cruciate ligament reconstruction reduces the OR occupancy time. Knee Surg Sports Traumatol Arthrosc. 2023 Jul;31(7):2917-2926. doi: 10.1007/s00167-022-07246-2. Epub 2022 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'Fiberoptic intubation is an important method for anesthesiologists to deal with difficult airways, but its operation is difficult and requires repeated practice. Fiberoptic intubation is performed in two steps. First, the anesthesiologist holds the bronchoscope and exposes the base of the tongue, the epiglottis, and the glottis successively according to the front camera of the bronchoscope. Through the glottis, the main trachea is exposed to the carina. This process is visual and the anesthesiologist can see the main tissue structure directly. Then, the endotracheal catheter enters the endotracheal along the bronchoscope, and the process of endotracheal catheter entry is not visual.\n\nIn clinical work, it was found that the tracheal catheter was easily blocked when it passed through the glottis, and it was necessary to adjust the position of the tracheal catheter for several times before the tracheal catheter could be sent into the tracheal tube, which was easy to cause throat injury in the process. At present, relevant studies are mainly focused on the first step of bronchoscopic intubation, how to quickly expose the glottis and complete the bronchoscopic guidance process. However, there is no clear mention of the situation of catatoning in the process of endotracheal catheter and how to solve the problem of catatoning.', 'detailedDescription': 'According to the inclusion and exclusion criteria，collecting the data of participants who undergone fiberoptic intubation. The observer analysis the safety and efficiency of fiberoptic intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in need of oral tube intubation and general anesthesia in our hospital for elective surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.American Society of Anesthesiologists 1\\~2\n\n2.18-60 year\n\n3.Adult patients requiring general anesthesia for orotracheal intubation\n\nExclusion Criteria:\n\n1. Limited mouth opening\n2. limited movement of temporomandibular joint\n3. abnormal glottic anatomy\n4. polyps of vocal cords'}, 'identificationModule': {'nctId': 'NCT06709118', 'briefTitle': 'The Effect of Different Fiberoptic Outer Diameters on Fiberoptic Intubation', 'organization': {'class': 'OTHER', 'fullName': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine'}, 'officialTitle': 'The Effect of Different Fiberoptic Outer Diameters on Fiberoptic Intubation', 'orgStudyIdInfo': {'id': 'KY-2024-172'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3.8mm Group', 'description': 'Orotracheal intubation was performed with a 3.8 millimeter outer diameter fiberoptic', 'interventionNames': ['Device: fiberoptic']}, {'label': '2.8 mm group', 'description': 'Orotracheal intubation was performed with a 2.8 millimeter outer diameter fiberoptic', 'interventionNames': ['Device: fiberoptic']}, {'label': '4.8mm group', 'description': 'Orotracheal intubation was performed with a 4.8 millimeter outer diameter fiberoptic', 'interventionNames': ['Device: fiberoptic']}], 'interventions': [{'name': 'fiberoptic', 'type': 'DEVICE', 'description': 'Tracheal intubation was performed with different outer diameters of fiberoptic.', 'armGroupLabels': ['2.8 mm group', '3.8mm Group', '4.8mm group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'qinye shi doctor, MD', 'role': 'CONTACT', 'email': '980276903@qq.com', 'phone': '8618367915826'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qinye Shi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The Fourth Affiliated Hospital of Zhejiang University Medical College', 'investigatorFullName': 'Qinye Shi', 'investigatorAffiliation': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine'}}}}