Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT04677894
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2020-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D013616', 'term': 'Tachycardia, Sinus'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013617', 'term': 'Tachycardia, Supraventricular'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007828', 'term': 'Laryngoscopy'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'targetDuration': '7 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2020-11-29', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': 'During surgery 0. minute', 'description': 'Heart Rate (HR)'}, {'measure': 'Heart Rate', 'timeFrame': 'During surgery 1. minute', 'description': 'Heart Rate (HR)'}, {'measure': 'Heart Rate', 'timeFrame': 'During surgery 3. minute', 'description': 'Heart Rate (HR)'}, {'measure': 'Heart Rate', 'timeFrame': 'During surgery 5. minute', 'description': 'Heart Rate (HR)'}, {'measure': 'Heart Rate', 'timeFrame': 'During surgery 10. minute', 'description': 'Heart Rate (HR)'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'During surgery 0. minute', 'description': 'Mean Arterial Pressure (MAP)'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'During surgery 1. minute', 'description': 'Mean Arterial Pressure (MAP)'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'During surgery 3. minute', 'description': 'Mean Arterial Pressure (MAP)'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'During surgery 5. minute', 'description': 'Mean Arterial Pressure (MAP)'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'During surgery 10. minute', 'description': 'Mean Arterial Pressure (MAP)'}, {'measure': 'Saturation', 'timeFrame': 'During surgery 0. minute', 'description': 'SpO2'}, {'measure': 'Saturation', 'timeFrame': 'During surgery 1. minute', 'description': 'SpO2'}, {'measure': 'Saturation', 'timeFrame': 'During surgery 3. minute', 'description': 'SpO2'}, {'measure': 'Saturation', 'timeFrame': 'During surgery 5. minute', 'description': 'SpO2'}, {'measure': 'Saturation', 'timeFrame': 'During surgery 10. minute', 'description': 'SpO2'}, {'measure': 'End Tidal Carbondioxide', 'timeFrame': 'During surgery 0. minute', 'description': 'EtCO2'}, {'measure': 'End Tidal Carbondioxide', 'timeFrame': 'During surgery 1. minute', 'description': 'EtCO2'}, {'measure': 'End Tidal Carbondioxide', 'timeFrame': 'During surgery 3. minute', 'description': 'EtCO2'}, {'measure': 'End Tidal Carbondioxide', 'timeFrame': 'During surgery 5. minute', 'description': 'EtCO2'}, {'measure': 'End Tidal Carbondioxide', 'timeFrame': 'During surgery 10. minute', 'description': 'EtCO2'}], 'secondaryOutcomes': [{'measure': 'Entubation Time', 'timeFrame': 'During Surgery 1.minute', 'description': 'Entubation time , (minute)'}, {'measure': 'Entubation Time', 'timeFrame': 'During Surgery 2.minute', 'description': 'Entubation time , (minute)'}, {'measure': 'Entubation Time', 'timeFrame': 'During Surgery 3.minute', 'description': 'Entubation time , (minute)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric oral surgery', 'direct laryngoscopy', 'video laryngoscopy', 'nasotracheal intubation'], 'conditions': ['Airway Complication of Anesthesia', 'Peroperative Complication', 'Intraoperative Hypertension', 'Tachycardia, Sinus', 'Desaturation of Blood']}, 'descriptionModule': {'briefSummary': 'Background and Objective: Airway control is a condition that should be evaluated primarily in anesthesia practice in the pediatric age group. Failed intubation or prolonged intubation duration can cause atelectasis and hypoxia in children. The aim of this study was to examine the effects of Macintosh laryngoscopy and McGrath videolaryngoscopy on hemodynamic parameters in pediatric patients who were scheduled to undergo elective dental surgery and required intubation for the application of general anesthesia.\n\nMethods: Sixty-six patients were divided into two groups according to the procedure used during intubation, namely, direct laryngoscopy or video laryngoscopy. The Cormack-Lehane and Mallampati scores, intubation duration, heart rate at minutes 0, 1, 3 and 5 during intubation, mean arterial pressure, EtCO2and SpO2 values were recorded for all the patients.', 'detailedDescription': 'Many techniques in the management of a difficult airway have been used in adult patients. In pediatric patients, awake fiberoptic intubation is difficult or even impossible . The video laryngoscope is a new tool produced by combining video technology and laryngoscope. Published studies on the video laryngoscope were mostly performed in adults . In this study, we used a Macintosh laryngoscope, which is a routinely used tool in anesthesiology, and a McGrath video laryngoscope, which is a type of a newly developed video laryngoscope that has not widely been used in the pediatric age group. The aim of this study was to examine the effects of Macintosh laryngoscopy and McGrath videolaryngoscopy on hemodynamic parameters in pediatric patients who were scheduled to undergo elective dental surgery and required intubation for the application of general anesthesia. We also evaluated whether Macintosh laryngoscopy and McGrath videolaryngoscopy improved the stress response and whether these approaches facilitated the intubation procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study included 66 ASA I-II patients with an age range of 4-13 years and who were scheduled for elective dental surgery under general anesthesia with intubation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy children between the ages of 4-13\n\n* Ordu University School of Medicine ,pediatric age group ,elective oral surgery 4-13 years and who were scheduled for elective oral surgery under general anesthesia with intubation If Patients with a Cormack -Lehane score 1,2 or 3 and if Mallampathy score of 1,2 or 3 were inccluded from the study\n\nExclusion Criteria:\n\n1. With malignancy disease patients\n2. with norological disorders\n3. with congenital heart disease\n4. with airway abnormality\n5. with airway disease patients\n6. Patients age Under 4 years , Above 13 years\n7. If Patients with a Cormack -Lehane score 4 and if Mallampathy score of 4 were excluded from the study -'}, 'identificationModule': {'nctId': 'NCT04677894', 'acronym': 'Laryngoscopy', 'briefTitle': 'Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ordu University'}, 'officialTitle': 'Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ECanakci'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group Direct Laringoscopy', 'description': 'Group DL: Group of patients intubated using a Macintoch blade laryngoscope.', 'interventionNames': ['Device: Laryngoscopy']}, {'label': 'Group Videolaringoscopy', 'description': 'Group VL: Group of patients intubated using a McGrath video laryngoscope.', 'interventionNames': ['Device: Laryngoscopy']}], 'interventions': [{'name': 'Laryngoscopy', 'type': 'DEVICE', 'description': 'During the intubation, the head of the patient was kept in a neutral position, patients were nasotracheally intubated', 'armGroupLabels': ['Group Direct Laringoscopy', 'Group Videolaringoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52200', 'city': 'Ordu', 'country': 'Turkey (Türkiye)', 'facility': 'Ordu University School of Medicine ,Department of Anesthesiology and Reanimation', 'geoPoint': {'lat': 40.97782, 'lon': 37.89047}}], 'overallOfficials': [{'name': 'Ebru Canakci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ordu University School of Medicine Department of Anesthesiology and Reanimation'}, {'name': 'Ahmet Gultekin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Namık Kemal University School of Medicine Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ordu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.,Associated Professor ,Head of Department of Anesthesiology and Reanimation', 'investigatorFullName': 'Ebru Canakci', 'investigatorAffiliation': 'Ordu University'}}}}