Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT04471467
Status:
UNKNOWN
Last Update Posted:
2020-07-21
First Post:
2020-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Tracheal Tube Fixation Method on Nasal Pressure of Patients With Nasal Tracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-18', 'studyFirstSubmitDate': '2020-07-12', 'studyFirstSubmitQcDate': '2020-07-14', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pressure between the nasal tube and nose', 'timeFrame': 'Immediately after procedure', 'description': 'pressure between the nasal tube and nose under different conditions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nasotracheal intubation', 'Pressure Injury'], 'conditions': ['Nasotracheal Intubation']}, 'descriptionModule': {'briefSummary': "Nasotracheal intubation (NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck .Various complications can occur such as epistaxis, bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or necrosis.In clinical practice, nasal pressure sores caused by NTI are not uncommon, but have failed to attract clinical attention.The investigators have observed that the surgeon fixed the nasal tracheal tube and threaded tube directly to the patient's head. The investigators suspect that this method can reduce the pressure between the nasal tube and the nose.", 'detailedDescription': "Nasotracheal intubation (NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck .Various complications can occur such as epistaxis, bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or necrosis.In clinical practice, nasal pressure sores caused by NTI are not uncommon, but have failed to attract clinical attention.Oral and maxillofacial surgery usually uses nasal endotracheal intubation to manage the airway. The tube fixation directly presses the skin of the patient's nose. Due to the operation, the surgeon must stand on the head of the patient and there is not enough space to place the tracheal tube bracket. Prolonged vascular compression on the nasal region may be caused by excessive tension and angulation of the nasotracheal tube against the nasal tissue.Studies have proposed the use of nasal packing, hydrocolloidal dressing and modified nasal tracheal tube to reduce the direct contact between the nasal tube and the nose, relieve the pressure between the two, so as to prevent the occurrence of alar pressure ulcers, but there is no objective data to show the degree of pressure reduction.In clinical practice, the investigatorshave observed surgeons fixed the nasal endotracheal tube and threaded the tube directly to the patient's head. The investigators suspect that this method can reduce the pressure between the nasal tube and the nose, so the investigators want to use a pressure sensor to monitor the pressure between the two."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who will be receiving general anesthesia with nasal intubation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-60 years old\n* ASA physical status I and II\n* Requiring general anesthesia with nasal intubation\n\nExclusion Criteria:\n\n* Previous history of pressure ulcers\n* Nasal trauma or defect\n* The need for emergency surgery\n* Contraindications to nasal intubation\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04471467', 'briefTitle': 'Effect of Tracheal Tube Fixation Method on Nasal Pressure of Patients With Nasal Tracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}, 'officialTitle': 'Effect of Tracheal Tube Fixation Method on Nasal Pressure of Patients With Nasal Tracheal Intubation', 'orgStudyIdInfo': {'id': 'PUs'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group F', 'description': 'Using tracheal tube fixation method （According to the needs of the surgery, the surgeon who did not participate in the trial）', 'interventionNames': ['Procedure: Fixed tracheal tube']}, {'label': 'group N', 'description': 'No tracheal tube fixation （According to the needs of the surgery, the surgeon who did not participate in the trial）'}], 'interventions': [{'name': 'Fixed tracheal tube', 'type': 'PROCEDURE', 'description': 'Tracheal tube fixation is determined by the surgeon according to the needs of the operation and is an independent process. Our research simply installed a monitoring device between the tube and the nose. The tube fixation takes place whether the observation of pressures is agreed to or not, as per standard protocol.', 'armGroupLabels': ['group F']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yu Sun, MD,PhD', 'role': 'CONTACT', 'email': 'dr_sunyu@163.com', 'phone': '0086-136-1189-5542'}, {'name': 'Wenyue Hu, MM', 'role': 'CONTACT', 'email': 'huwenyue08@163.com', 'phone': '0086-180-1918-0376'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yu Sun', 'investigatorAffiliation': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}}}}