Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-27 @ 7:50 PM
Study NCT ID:
NCT02578992
Status:
COMPLETED
Last Update Posted:
2016-12-09
First Post:
2015-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
"Neutral Head Position" and "Head-lift Position" for Orotracheal Intubation With "Trachway" Intubating Stylet in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'whcken@gmail.com', 'phone': '+886-2-87927128', 'title': 'Dr. Wei-Hung Chan', 'organization': 'Tri-Service General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Tracheal intubation with Trachway was performed by an novice anesthesiologist.'}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Head-lift Position', 'description': "The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique\n\nHead-lift position: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.\n\n7cm high pillow: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.", 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Neutral Position', 'description': "The patients' head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique", 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intubation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Head-lift Position', 'description': "The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique\n\nHead-lift position: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.\n\n7cm high pillow: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation."}, {'id': 'OG001', 'title': 'Neutral Position', 'description': "The patients' head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique"}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '20'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '23.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts', 'description': 'the interval from the intubating stylet touched the mouth to capnogram shown, with all attempts, and was recorded by an independent observer with a stop watch.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Cormack-Lehane Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neutral Head Position', 'description': 'The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.'}, {'id': 'OG001', 'title': 'Head-lift Position', 'description': 'The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.53', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '1.83', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during intubation, after epiglottis was identified on the video monitor', 'description': 'The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.\n\nScale range (1, 2, 3, 4). Grade 1 is considered to be a better outcome while grade 4 is considered to be a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Arterial Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neutral Head Position', 'description': 'Hemodynamic variables were recorded 3 min before, and 1, 3, and 5 min after intubation.'}, {'id': 'OG001', 'title': 'Head-lift Position', 'description': 'Hemodynamic variables were recorded 3 min before, and 1, 3, and 5 min after intubation.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'spread': '14', 'groupId': 'OG000'}, {'value': '86', 'spread': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after intubation, up to 5 minutes', 'description': 'compare the mean arterial pressure between two groups.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale of Sore Throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neutral Head Position', 'description': 'All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit'}, {'id': 'OG001', 'title': 'Head-lift Position', 'description': 'All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit'}], 'classes': [{'categories': [{'measurements': [{'value': '1.82', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.73', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after anesthesia emergence 30 minutest, at post-anesthesia care unit', 'description': 'All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit.\n\nScale range: 0-10. 0 is considered to be a better outcome while 10 is a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Head-lift Position', 'description': "The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique\n\nHead-lift position: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.\n\n7cm high pillow: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation."}, {'id': 'FG001', 'title': 'Neutral Position', 'description': "The patients' head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'November 2014', 'groupId': 'FG000', 'numSubjects': '65'}, {'comment': 'November 2014', 'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'October 2015', 'groupId': 'FG000', 'numSubjects': '62'}, {'comment': 'October 2015', 'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'equipment not available or malfunction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Patients aged 20-80 years who were scheduled for various surgeries requiring general anesthesia with tracheal intubation were recruited. All patients exhibited an American Society of Anesthesiologists physical status of I-III. From November 2014 to October 2015', 'preAssignmentDetails': 'Patient denied to participated, equipment unavailable or malfunction, difficult mask ventilation were excluded .'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Head-lift Position', 'description': "The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position) and then the patient was intubated with Trachway by single-handed chin lift technique\n\nHead-lift position: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.\n\n7cm high pillow: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation."}, {'id': 'BG001', 'title': 'Neutral Position', 'description': "The patients' head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '50.0', 'spread': '15.0', 'groupId': 'BG001'}, {'value': '50.8', 'spread': '14.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height, Thyromental distance, Sternomental distance, Neck length', 'classes': [{'title': 'Height', 'categories': [{'measurements': [{'value': '162.3', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '161.9', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '162', 'spread': '9', 'groupId': 'BG002'}]}]}, {'title': 'Thyromental distance', 'categories': [{'measurements': [{'value': '7.7', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '7.8', 'spread': '1.0', 'groupId': 'BG002'}]}]}, {'title': 'Sternomental distance', 'categories': [{'measurements': [{'value': '15.2', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '15.7', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '15.5', 'spread': '1.8', 'groupId': 'BG002'}]}]}, {'title': 'Neck Length', 'categories': [{'measurements': [{'value': '16.7', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '17.3', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '17.0', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '66.08', 'spread': '15.8', 'groupId': 'BG000'}, {'value': '66', 'spread': '12', 'groupId': 'BG001'}, {'value': '66', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'age from 20-80'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2015-10-13', 'resultsFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2015-10-16', 'lastUpdatePostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-17', 'studyFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation Time', 'timeFrame': 'from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts', 'description': 'the interval from the intubating stylet touched the mouth to capnogram shown, with all attempts, and was recorded by an independent observer with a stop watch.'}], 'secondaryOutcomes': [{'measure': 'Modified Cormack-Lehane Grade', 'timeFrame': 'during intubation, after epiglottis was identified on the video monitor', 'description': 'The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.\n\nScale range (1, 2, 3, 4). Grade 1 is considered to be a better outcome while grade 4 is considered to be a worse outcome.'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'before and after intubation, up to 5 minutes', 'description': 'compare the mean arterial pressure between two groups.'}, {'measure': 'Visual Analog Scale of Sore Throat', 'timeFrame': 'after anesthesia emergence 30 minutest, at post-anesthesia care unit', 'description': 'All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit.\n\nScale range: 0-10. 0 is considered to be a better outcome while 10 is a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intubating stylet', 'head and neck position'], 'conditions': ['Intubation; Difficult']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate two different patient\'s head and neck positions(neutral head position and head-lift position) for the effectiveness of orotracheal intubation with using the "Clarus Video System (Trachway®)" intubating stylet.', 'detailedDescription': 'The sniffing position has traditionally been considered the optimal head position for direct laryngoscopy, However, it may aggravate cervical spine injury. The Trachway® video stylet is an intubating device that may avoid cervical movement during intubation. Nonetheless, the effectiveness of limited neck movement in patients with neutral head or head-lift position using the Trachway® video stylet remains unclear. The purpose of this study was to compare the intubation time of the two positions with the Trachway® video stylet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for various surgeries requiring general anesthesia with tracheal intubation\n* American Society of Anesthesiologists(ASA) physical status classification I-III\n\nExclusion Criteria:\n\n* pneumothorax\n* room air saturation by pulse oximeter saturation less than 96%\n* vocal cord palsy\n* craniofacial anomaly\n* congenital upper airway anomaly\n* upper airway disease\n* cervical spine pathology\n* head and neck tumor status post radiotherapy\n* an increased risk of regurgitation or pulmonary aspiration\n* a history of difficult tracheal intubation'}, 'identificationModule': {'nctId': 'NCT02578992', 'briefTitle': '"Neutral Head Position" and "Head-lift Position" for Orotracheal Intubation With "Trachway" Intubating Stylet in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': '"Neutral Head Position" and "Head-lift Position" for Orotrachwal Intubation With "Trachway" Intubating Stylet in Adults', 'orgStudyIdInfo': {'id': '2-103-05-125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Head-lift Position', 'description': "The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position) and then the patient was intubated with Trachway by single-handed chin lift technique", 'interventionNames': ['Procedure: Head-lift position', 'Device: 7cm high pillow']}, {'type': 'NO_INTERVENTION', 'label': 'Neutral Position', 'description': "The patients' head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique"}], 'interventions': [{'name': 'Head-lift position', 'type': 'PROCEDURE', 'description': "A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.", 'armGroupLabels': ['Head-lift Position']}, {'name': '7cm high pillow', 'type': 'DEVICE', 'description': "A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.", 'armGroupLabels': ['Head-lift Position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Wei-Hung Chan', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}