Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT01630694
Status:
TERMINATED
Last Update Posted:
2016-01-20
First Post:
2011-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway
Sponsor:
Organization:
Raw JSON
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This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.\n\n3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.\n\n3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Hyomental Distance Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Difficult Intubation Patients', 'description': 'Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.\n\n3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.\n\n3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of study approximately one year', 'description': 'A curved low-frequency transducer and a Flex focul 400 ultrasound system were used to visualize the tongue and shadows of the hyoid bone and mandible. Midsagittal and coronal/transverse scans from the ultrasound were analyzed using ImageJ. The hyomental distances in the neutral and heal-extended positions were measured from the upper border of the hyoid bone to the lower border of the mentum. The ratio is defined as the ratio of the hyomental distance at the extreme of head extension to that in the neutral position.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only 6 patients in each group were analyzed because the remaining patients were not eligible for analysis based on a review of their electronic medical chart'}, {'type': 'SECONDARY', 'title': 'Mean Tongue Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Difficult Intubation Patients', 'description': 'Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.\n\n3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.\n\n3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed.'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'spread': '29', 'groupId': 'OG000'}, {'value': '168', 'spread': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of study approximately one year', 'description': 'The midsagittal scans were used to measure the cross-sectional area of the tongue. Transverse scans obtained in the midsection of the tongue (at the glossal end of the genioglossus muscle) provided a measure of the tongue width, which was measured between the most distant points on its upper surface. The tongue volume was derived from the multiplication of the midsagittal cross-sectional area by the tongue width.', 'unitOfMeasure': 'cubic centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only 6 patients in each group were analyzed because the remaining patients were not eligible for analysis based on a review of their electronic medical chart'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Difficult Intubation Patients', 'description': 'Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.\n\n3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.\n\n3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period for this study is from 11-3-2010 to 10-1-2012 done in a medical clinic setting.', 'preAssignmentDetails': 'Enrollment goal for this study was met so the study was closed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Difficult Intubation Patients', 'description': 'Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.\n\n3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.\n\n3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Males and Females 18 years and older'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'study stopped due to not meeting enrollment goal.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2011-08-16', 'resultsFirstSubmitDate': '2015-11-02', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-14', 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Hyomental Distance Ratio', 'timeFrame': 'end of study approximately one year', 'description': 'A curved low-frequency transducer and a Flex focul 400 ultrasound system were used to visualize the tongue and shadows of the hyoid bone and mandible. Midsagittal and coronal/transverse scans from the ultrasound were analyzed using ImageJ. The hyomental distances in the neutral and heal-extended positions were measured from the upper border of the hyoid bone to the lower border of the mentum. The ratio is defined as the ratio of the hyomental distance at the extreme of head extension to that in the neutral position.'}], 'secondaryOutcomes': [{'measure': 'Mean Tongue Volume', 'timeFrame': 'end of study approximately one year', 'description': 'The midsagittal scans were used to measure the cross-sectional area of the tongue. Transverse scans obtained in the midsection of the tongue (at the glossal end of the genioglossus muscle) provided a measure of the tongue width, which was measured between the most distant points on its upper surface. The tongue volume was derived from the multiplication of the midsagittal cross-sectional area by the tongue width.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Difficult airway management', 'anesthesia', 'difficult intubation'], 'conditions': ['Failed or Difficult Intubation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify differences in craniofacial morphology and tongue size between patients who have a history of difficult airway management and a control group of patients who had an uneventful airway management during induction of general anesthesia. In this study the investigators want to validate the hypothesis that there are craniofacial phenotypic differences between patients who have a history of difficult airway management and a control group of patients who have had an uneventful airway management during the induction of general anesthesia.', 'detailedDescription': 'Difficult airway management is one of the most challenging tasks for anesthesiologists. Recent data from the American Society of Anesthesiologists (ASA) Management Closed Claims Project \\[1\\] show that the percentage of claims resulting from adverse respiratory events, though on the decline (42% in the 1980s to 32% in the 1990s), continue to constitute a large source of morbidity and mortality in anesthetized patients. In 2005, a closed claims analysis of trends in anesthesia-related death and brain damage between 1975 and 2000 showed that out of all respiratory events (n=503) responsible for death and brain damage, difficult endotracheal intubation (n=115), inadequate oxygenation (n=111) and inadvertent esophageal intubation (n=66) were the top three causes \\[2\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients that had undergone or will undergo a surgery under general anesthesia .\n\nExclusion Criteria:\n\n* known history of syndromal craniofacial abnormalities (e.g. Down syndrome)\n* previous craniofacial surgery\n* excessive facial hair which significantly obscure facial landmarks\n* cervical spine fractures\n* tracheostomy tube\n* patients who are unable to give consent'}, 'identificationModule': {'nctId': 'NCT01630694', 'briefTitle': 'Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Three -Dimensional (3-D) Craniofacial Phenotyping of Patients With Difficult Airway', 'orgStudyIdInfo': {'id': 'RSRB case number: 00032136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Difficult intubation patients', 'description': 'patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.', 'interventionNames': ['Procedure: 3D Laser Scanning of the Head', "Procedure: Measurements and Digital Photo's of the head, neck and Mouth", 'Procedure: Ultrasound Exam of the Tongue']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The control group will consist of patients with the easy laryngoscopy and intubation, recruited prospectively.', 'interventionNames': ['Procedure: 3D Laser Scanning of the Head', "Procedure: Measurements and Digital Photo's of the head, neck and Mouth", 'Procedure: Ultrasound Exam of the Tongue']}], 'interventions': [{'name': '3D Laser Scanning of the Head', 'type': 'PROCEDURE', 'otherNames': ['Konica Minolta 3D Digitizing Konica Minolta 3D laser scanner'], 'description': 'Five scans will be collected from different angles, each scan taking approximately 3 seconds. Each scan will consist of a thin beam of light flashing of your head.', 'armGroupLabels': ['Control']}, {'name': "Measurements and Digital Photo's of the head, neck and Mouth", 'type': 'PROCEDURE', 'otherNames': ['General Electric Total access ultrasound'], 'description': 'Prior to the photographs, certain bone and soft tissue areas such as angle of the jaw, neck and chin will be gently touched and marked with self-adhesive paper stickers. Using the self-adhesive paper stickers and a measuring tape, we obtain measurements of your head and neck. You will be also asked to open your mouth and a digital photograph of the back of the mouth will be taken, as well as, pictures of the front and side of the head and neck.', 'armGroupLabels': ['Control']}, {'name': 'Ultrasound Exam of the Tongue', 'type': 'PROCEDURE', 'otherNames': ['General Electric Total access ultrasound'], 'description': 'The ultrasound study of the tongue will be performed after the series of laser scans. You will be examined in the sitting position. A small,handheld, curved ultrasound instrument will be placed under the chin to take images of the tongue. This exam should take less than a minute', 'armGroupLabels': ['Control']}, {'name': '3D Laser Scanning of the Head', 'type': 'PROCEDURE', 'otherNames': ['3D digitizing Konica Minolta 3D laser scanner'], 'description': 'Five scans will be collected from different angles, each scan taking approximately 3 seconds. Each scan will consist of a thin beam of light flashing of your head.', 'armGroupLabels': ['Difficult intubation patients']}, {'name': "Measurements and Digital Photo's of the head, neck and Mouth", 'type': 'PROCEDURE', 'otherNames': ['3D digitizing konica minolta 3D laser scanner'], 'description': 'Prior to the photographs, certain bone and soft tissue areas such as angle of the jaw, neck and chin will be gently touched and marked with self-adhesive paper stickers. Using the self-adhesive paper stickers and a measuring tape, we obtain measurements of your head and neck.Digital Photographs of your Mouth - You will be also asked to open your mouth and a digital photograph of the back of the mouth will be taken, as well as, pictures of the front and side of the head and neck.', 'armGroupLabels': ['Difficult intubation patients']}, {'name': 'Ultrasound Exam of the Tongue', 'type': 'PROCEDURE', 'otherNames': ['General Electric Total Access ultrasound'], 'description': 'The ultrasound study of the tongue will be performed after the series of laser scans. You will be examined in the sitting position. A small,handheld, curved ultrasound instrument will be placed under the chin to take images of the tongue. This exam should take less than a minute.', 'armGroupLabels': ['Difficult intubation patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Jacek Wojtczak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jacek Wojtczak', 'investigatorAffiliation': 'University of Rochester'}}}}