Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT01685320
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2012-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm.carassiti@unicampus.it', 'phone': '+39-06-225411952', 'title': 'Prof. Massimiliano Carassiti', 'organization': 'Campus Bio-medico University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '1. Patients studied were classified with "normal airways", while difficult intubations were not considered.\n2. We excluded patients with CL grade 2 or greater.\n3. We employed only the Macintosh size 3 blade to avoid additional variables.'}}, 'adverseEventsModule': {'description': 'Serious and/or other non-serious adverse events were not collected/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'Direct Laryngoscope', 'description': 'Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Indirect Laryngoscope', 'description': 'Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Direct Laryngoscope', 'description': 'Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.'}, {'id': 'OG001', 'title': 'Indirect Laryngoscope', 'description': 'Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.'}], 'classes': [{'title': 'Measurements during glottis visualization', 'categories': [{'measurements': [{'value': '16', 'spread': '6', 'groupId': 'OG000'}, {'value': '10', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Measurements during intubation', 'categories': [{'measurements': [{'value': '40', 'spread': '14', 'groupId': 'OG000'}, {'value': '8', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia', 'description': 'The pressure distribution exerted upon the tissues by the blade was measured (in Newton)through pressure film transducers put on the blade of both direct and indirect laryngoscopes, in order to compare the two devices.', 'unitOfMeasure': 'Newton', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.'}, {'type': 'SECONDARY', 'title': 'Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Direct Laryngoscope', 'description': 'Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.'}, {'id': 'OG001', 'title': 'Indirect Laryngoscope', 'description': 'Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.'}], 'classes': [{'title': 'Time measured during glottis visualization', 'categories': [{'measurements': [{'value': '13', 'spread': '1', 'groupId': 'OG000'}, {'value': '7', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Time measured during intubation', 'categories': [{'measurements': [{'value': '22', 'spread': '3', 'groupId': 'OG000'}, {'value': '20', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On average 20 seconds', 'description': 'Since the time needed for laryngoscopy and intubation could represent one of the major contributors to the stress response during these procedures, times to achieve the glottis visualization and to perform the entire intubation were recorded.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Direct Laryngoscope', 'description': 'Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.'}, {'id': 'FG001', 'title': 'Indirect Laryngoscope', 'description': 'Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Date of recruitment period: January-October 2011. Type of location: Dept. of Anaesthesia, University School of Medicine Campus Bio-Medico, Rome, Italy.', 'preAssignmentDetails': 'After written consent, thirty adult patients scheduled for elective surgery under general anaesthesia (age between 18 and 65 years, body-mass index between 18 and 30, classified as ASA-PS class 1 or 2), were included in this study. Subjects likely to be difficult to intubate, according to the SIAARTI Recommendations, were excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Direct Laryngoscope', 'description': 'Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.'}, {'id': 'BG001', 'title': 'Indirect Laryngoscope', 'description': 'Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.'}, {'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': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '12', 'groupId': 'BG000'}, {'value': '44', 'spread': '11', 'groupId': 'BG001'}, {'value': '42.5', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2012-09-07', 'resultsFirstSubmitDate': '2013-02-08', 'studyFirstSubmitQcDate': '2012-09-11', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-02-08', 'studyFirstPostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.', 'timeFrame': 'Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia', 'description': 'The pressure distribution exerted upon the tissues by the blade was measured (in Newton)through pressure film transducers put on the blade of both direct and indirect laryngoscopes, in order to compare the two devices.'}], 'secondaryOutcomes': [{'measure': 'Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation', 'timeFrame': 'On average 20 seconds', 'description': 'Since the time needed for laryngoscopy and intubation could represent one of the major contributors to the stress response during these procedures, times to achieve the glottis visualization and to perform the entire intubation were recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Force', 'Pressure', 'Intubation', 'laryngoscopy'], 'conditions': ['Tracheal Intubation', 'Laryngoscopy']}, 'referencesModule': {'references': [{'pmid': '21965048', 'type': 'RESULT', 'citation': 'Carassiti M, Zanzonico R, Cecchini S, Silvestri S, Cataldo R, Agro FE. Force and pressure distribution using Macintosh and GlideScope laryngoscopes in normal and difficult airways: a manikin study. Br J Anaesth. 2012 Jan;108(1):146-51. doi: 10.1093/bja/aer304. Epub 2011 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'Forces applied on soft upper tissues by different laryngoscope blades during direct laryngoscopy and intubation are considered to be major stimuli to cause serious damages to the patients. The aim of this study is to compare the force and pressure applied to soft tissue in order to achieve the same glottis view comparing direct laryngoscopy and videolaryngoscopy in vivo.', 'detailedDescription': 'Forces applied on soft upper tissues by different laryngoscope blades during direct laryngoscopy and intubation are considered to be major stimuli to cause serious damages to the patients, such as local injures to incisors, larynx and spinal column, or hemodynamic changes in heart rate and/or blood pressure due to autonomic nervous system stimulation.\n\nIn order to reduce risk of such injures, indirect videolaryngoscopy provides the advantage of an easier laryngeal visualization with less need for the mouth-pharyngeal-laryngeal axes alignment, thereby reducing the detrimental effects above mentioned.\n\nThe aim of this study is to measure the minimal force exertion to achieve not only glottis view but also a successful intubation, comparing GlideScope and Macintosh laryngoscope, in patients with normal airway conditions. Furthermore, The investigators measured the following parameters: pressure distribution upon the blade; time required to visualize the glottis; time required to complete oro-tracheal intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients classified as American Society of Anesthesiologists physical status (ASA-PS) class 1 or 2\n* Patients whose intubation was associated with a Cormack-Lehane grade 1\n\nExclusion Criteria:\n\n* younger than 18 yrs\n* older than 65 yrs\n* body-mass index (BMI) between 18 and 30\n* predicted difficult intubation according to SIAARTI (Italian Society Anaesthesia, Analgesia, Resuscitation and Intensive Care)'}, 'identificationModule': {'nctId': 'NCT01685320', 'briefTitle': 'Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study', 'organization': {'class': 'OTHER', 'fullName': 'Campus Bio-Medico University'}, 'officialTitle': 'Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study', 'orgStudyIdInfo': {'id': 'PressureCara'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Direct laryngoscope', 'description': 'Includes cases in which the forces applied by Macintosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured.', 'interventionNames': ['Procedure: Forces applied by laryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Indirect laryngoscope', 'description': 'Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured.', 'interventionNames': ['Procedure: Forces applied by laryngoscope']}], 'interventions': [{'name': 'Forces applied by laryngoscope', 'type': 'PROCEDURE', 'description': 'Force and pressure distribution applied by direct or indirect laryngoscope during glottis visualization and intubation were measured using film pressure transducers.', 'armGroupLabels': ['Direct laryngoscope', 'Indirect laryngoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00128', 'city': 'Rome', 'country': 'Italy', 'facility': 'University Hospital Campus BioMedico', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Massimiliano Carassiti, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Campus BioMedico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Campus Bio-Medico University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Massimiliano Carassiti', 'investigatorAffiliation': 'Campus Bio-Medico University'}}}}