Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT03226002
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Which Nostril Should be Used for Nasotracheal Intubation With Airtraq NT®: the Right or Left? A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-06', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insertion time of the device', 'timeFrame': '20 seconds', 'description': 'handling the device till the optimal glottis visualization occurred'}, {'measure': 'nasotracheal intubation time with the device', 'timeFrame': '30 seconds', 'description': 'handling the device till the visualization of tracheal tube through the vocal cords'}, {'measure': 'total nasotracheal intubation time with the device', 'timeFrame': '40 seconds', 'description': 'handling the device till the confirmation of nasotracheal intubation with end-tidal carbodioxide'}], 'secondaryOutcomes': [{'measure': 'optimisation maneuvers during intubation with the device', 'timeFrame': '20 seconds', 'description': 'need for optimisation maneuvers during nasotracheal intubation'}, {'measure': 'minor complications related to the device', 'timeFrame': '40 seconds', 'description': 'epistaxis, nose pain, bronchospasm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Airtraq NT', 'nasotracheal intubation', 'right', 'left'], 'conditions': ['Nasotracheal Intubation']}, 'descriptionModule': {'briefSummary': 'After Ethics committee approval investigators decided to enroll 40 patients ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. We primay aimed to compare the glottis visualization time, intubation time and total intubation times.', 'detailedDescription': 'After Ethics committee approval, investigators decided to enroll 40 pateints ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. In addition is the 90° anti-clockwise rotation of the tip of the tube helpful to insert the tube into the trachea. Patients were randomized into right and the left nostril groups. After standard anesthesia induction with propofol and fentanyl, rocuronium was used for muscle relaxation. Primary aim of this prospective study was to compare the glottis visualization time, intubation time and total intubation times. The Cormack-Lehane grades, the need for optimization, tube adjustment maneuvers, hemodynamic data, occurrence of epistaxis of the patients were recorded during the process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age\n* undergoing elective maxillofacial surgery\n* dental surgery\n* plastic surgery requiring nasotracheal intubation\n* ASA I-II\n\nExclusion Criteria:\n\n* \\>18 years and \\> 65 years\n* BMI\\> 35\n* ASA III-IV\n* fasted patients\n* patients do not require nasotracheal intubation'}, 'identificationModule': {'nctId': 'NCT03226002', 'briefTitle': 'Which Nostril Should be Used for Nasotracheal Intubation With Airtraq NT®: the Right or Left? A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Which Nostril Should be Used for Nasotracheal Intubation With Airtraq NT®: the Right or Left? A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'KÜ GOKAEK 2017/71'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Airtraq NT right nostril', 'description': 'nasotracheal intubation with Airtraq NT through the right nostril', 'interventionNames': ['Device: Airtraq NT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Airtraq NT left nostril', 'description': 'nasotracheal intubation with Airtraq NT through the left nostril', 'interventionNames': ['Device: Airtraq NT']}], 'interventions': [{'name': 'Airtraq NT', 'type': 'DEVICE', 'description': 'channeled video laryngoscope for nasotracheal intubation', 'armGroupLabels': ['Airtraq NT left nostril', 'Airtraq NT right nostril']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41900', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University School of Medicine', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'zehra I Arslan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Zehra Ipek ARSLAN', 'investigatorAffiliation': 'Kocaeli University'}}}}