Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT05559502
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2022-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Flow Nasal Oxygenation vs Endotracheal Intubation on Recovery Profiles in Laryngeal Microsurgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-26', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade of Emergence cough during periextubation period', 'timeFrame': 'From end of surgery to extubation', 'description': 'Grade Score (grade 0=no cough, grade 1=light or single cough, grade 2=moderate cough or more than one episode of nonsustained coughing, grade 3=sustained and repetitive cough movements with head lift, 0 is the minimum value which is a better outcome and 3 is the maximum value which is a worse outcome.)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with postoperative airway complications', 'timeFrame': 'from 1 hour after surgery to 24 hours after surgery', 'description': 'post operative sore throat'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High flow nasal oxygenation', 'Laryngeal microsurgery', 'emergence cough'], 'conditions': ['Cough']}, 'descriptionModule': {'briefSummary': 'Transnasal humidified rapid-insufflation ventilatory exchange(THRIVE), or also termed high flow nasal oxygenation (HFNO) is a method of supplying heated, humidified high concentrations of oxygen via nasal cavity. This study hypothesizes that in general anesthesia for laryngeal microsurgery, high-flow nasal oxygen without endotracheal intubation reduces cough during the emergence period compared to endotracheal intubation.', 'detailedDescription': 'Laryngeal microsurgery is mainly performed by a conventional method of general anesthesia with endotracheal intubation (ET), which may have difficulty accessing the lesion behind the larynx, and may be limited in securing space for surgical manipulation. To compensate for these shortcomings, a method of maintaining general anesthesia without using an endotracheal tube has been introduced, and high-flow nasal oxygen(HFNO) and transnasal humidified rapid insufflation ventilatory exchange(THRIVE) enable tubeless anesthesia due to apnea oxygenation and apnea ventilation effect during laryngeal microsurgery. Coughing and straining can be accompanied by emergence after general anesthesia. Forceful vocal cord adduction especially after upper respiratory surgery such as laryngeal microsurgery can cause damage and bleeding of surgical tissue, delaying wound healing. If a small amount of remifentanil is continuously injected during emergence after total intravenous anesthesia(TIVA), airway complications such as coughing can be reduced during emergence without delay in recovery time, and hemodynamic stability can be promoted. In this study, the effect of endotracheal intubation and high-flow nasal oxygen on the emergence cough and postoperative sore throat is compared when total intravenous anesthesia(TIVA) using propofol and remifentanil is performed in patients undergoing laryngeal microsurgery. This study hypothesizes that in general anesthesia for laryngeal microsurgery, high-flow nasal oxygen without endotracheal intubation reduces cough during the emergence period compared to endotracheal intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with American Society of Anesthesiologists classification 1 or 2 who receive general anesthesia for laryngeal microsurgery\n\nExclusion Criteria:\n\n* Patients with major cardiovascular, pulmonary, and cerebrovascular disease\n* Laser laryngeal surgery\n* Morbid obesity (BMI\\>35 kg/m2)'}, 'identificationModule': {'nctId': 'NCT05559502', 'briefTitle': 'High Flow Nasal Oxygenation vs Endotracheal Intubation on Recovery Profiles in Laryngeal Microsurgery', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Comparison of High Flow Nasal Oxygenation Versus Endotracheal Intubation on Recovery Profiles in Laryngeal Microsurgery', 'orgStudyIdInfo': {'id': 'AJOUIRB-IV-2022-457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HFNO group', 'description': 'Patients will receive HFNO therapy during laryngomicrosurgery.', 'interventionNames': ['Device: HFNO group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ET group', 'description': 'Endotracheal intubation was performed for general anesthesia', 'interventionNames': ['Device: ET group']}], 'interventions': [{'name': 'HFNO group', 'type': 'DEVICE', 'otherNames': ['Optiflow'], 'description': 'HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.', 'armGroupLabels': ['HFNO group']}, {'name': 'ET group', 'type': 'DEVICE', 'otherNames': ['Portex, Smiths Medical International Ltd., South East England, United Kingdom'], 'description': 'Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.', 'armGroupLabels': ['ET group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443-721', 'city': 'Suwon', 'state': 'Gyeongki-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong Yeop Kim, M.D., Ph.D.', 'role': 'CONTACT'}, {'name': 'Tae Kwang Kim, M.D', 'role': 'CONTACT'}, {'name': 'Jong Yeop Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'TaeKwang Kim, M.D.', 'role': 'CONTACT', 'email': 'tk.kim@aumc.ac.kr', 'phone': '82-031-219-5589'}, {'name': 'JongYeop Kim, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'kjyeop@ajou.ac.kr', 'phone': '82-031-219-5574'}], 'overallOfficials': [{'name': 'JongYeop Kim, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jong Yeop Kim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}