Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-04-24 @ 4:30 AM
Study NCT ID:
NCT02387502
Status:
COMPLETED
Last Update Posted:
2015-05-04
First Post:
2015-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Three Laryngoscopes in Difficult Laryngoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bhandari_geetantl@rediff.com', 'phone': '8958267145', 'title': 'Dr. Geeta Bhandari', 'organization': 'Govt. Medical College, Haldwani.'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The intubating anesthetist was not blind to the randomization of the laryngoscope. This could have led to bias. However, the primary outcome i.e. time of intubation was well defined and objective.'}}, 'adverseEventsModule': {'timeFrame': 'up to 30 minutes after extubation', 'eventGroups': [{'id': 'EG000', 'title': 'Intubation With Macintosh Laryngoscope', 'description': 'After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.\n\nIntubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Intubation With MacCoy Laryngoscope', 'description': 'After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.\n\nIntubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Intubation With Airtraq Laryngoscope', 'description': 'After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.\n\nIntubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 8}], 'seriousEvents': [{'term': 'Airway trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time of Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intubation With Macintosh Laryngoscope', 'description': 'After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.\n\nIntubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.'}, {'id': 'OG001', 'title': 'Intubation With MacCoy Laryngoscope', 'description': 'After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.\n\nIntubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.'}, {'id': 'OG002', 'title': 'Intubation With Airtraq Laryngoscope', 'description': 'After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.\n\nIntubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.22', 'spread': '4.72', 'groupId': 'OG000'}, {'value': '37.62', 'spread': '3.45', 'groupId': 'OG001'}, {'value': '27.80', 'spread': '3.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 10 minutes', 'description': 'Time of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intubation With Macintosh Laryngoscope', 'description': 'After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.\n\nIntubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.'}, {'id': 'FG001', 'title': 'Intubation With MacCoy Laryngoscope', 'description': 'After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.\n\nIntubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.'}, {'id': 'FG002', 'title': 'Intubation With Airtraq Laryngoscope', 'description': 'After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.\n\nIntubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '120 patients were recruited for the study. Recruitment process started in January 2014 and the study ended in December 2014. patients were recruited in the operating rooms of a tertiary care teaching hospital.', 'preAssignmentDetails': '30 patients were excluded from the study for not meeting the inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Intubation With Macintosh Laryngoscope', 'description': 'After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.\n\nIntubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.'}, {'id': 'BG001', 'title': 'Intubation With MacCoy Laryngoscope', 'description': 'After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.\n\nIntubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.'}, {'id': 'BG002', 'title': 'Intubation With Airtraq Laryngoscope', 'description': 'After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.\n\nIntubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.35', 'spread': '9.92', 'groupId': 'BG000'}, {'value': '38.82', 'spread': '9.62', 'groupId': 'BG001'}, {'value': '35.47', 'spread': '10.10', 'groupId': 'BG002'}, {'value': '37.88', 'spread': '9.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '58.65', 'spread': '6.03', 'groupId': 'BG000'}, {'value': '58.62', 'spread': '6.46', 'groupId': 'BG001'}, {'value': '57.62', 'spread': '5.65', 'groupId': 'BG002'}, {'value': '58.30', 'spread': '6.05', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '22.41', 'spread': '1.11', 'groupId': 'BG000'}, {'value': '22.43', 'spread': '1.07', 'groupId': 'BG001'}, {'value': '22.03', 'spread': '1.13', 'groupId': 'BG002'}, {'value': '22.29', 'spread': '1.10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mallampati grade', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'BG003', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Mallampati classification is based on the structures visualized with maximal mouth opening and tongue protrusion in the sitting position.\n\nClass I: Soft palate, uvula, fauces, pillars visible. Class II: Soft palate, uvula, fauces visible. Class III: Soft palate, base of uvula visible. Class IV: Only hard palate visible.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Thyromental distance', 'classes': [{'categories': [{'measurements': [{'value': '6.19', 'spread': '0.40', 'groupId': 'BG000'}, {'value': '6.16', 'spread': '0.40', 'groupId': 'BG001'}, {'value': '6.28', 'spread': '0.44', 'groupId': 'BG002'}, {'value': '6.21', 'spread': '0.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-28', 'studyFirstSubmitDate': '2015-03-02', 'resultsFirstSubmitDate': '2015-03-27', 'studyFirstSubmitQcDate': '2015-03-12', 'lastUpdatePostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-28', 'studyFirstPostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of Intubation', 'timeFrame': 'up to 10 minutes', 'description': 'Time of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intubation; Difficult']}, 'descriptionModule': {'briefSummary': "Tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. When these three axes are not aligned, intubation becomes difficult. In the researchers' study, the investigators simulated difficult laryngoscopy situation by using a rigid neck collar. This neck collar renders intubation difficult not only by restricting neck movement, but also reducing mouth opening. The investigators compared the performance of Macintosh, MacCoy and Airtraq laryngoscope in simulated difficult laryngoscopy using a rigid neck collar.", 'detailedDescription': "Airtraq laryngoscope is an optical laryngoscope which allows visualization of vocal cord as a reflected image through multiple lenses and prisms. MacCoy laryngoscope is a modification of Macintosh laryngoscope. It has a lever which, when pressed, moves its flexible tip. In the investigators' study, the researchers compared the performances of Airtraq laryngoscope with MacCoy and Macintosh laryngoscopes in simulated difficult laryngoscopy using a rigid neck collar. The researchers recruited 120 patients and randomly divided those patients into three equal groups i.e. 30 patients in each group. These three groups are 1-Airtraq, 2-MacCoy and 3-Macintosh. The researchers compared efficacy and safety in these three laryngoscopes. The researchers compared efficacy in terms of time of intubation, ease of intubation, overall success, Intubation difficulty score, visualization of vocal cord in terms of POGO (percentage of Glottic Opening) score. The researchers compared safety in terms of hemodynamic pressor response and airway trauma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I and II.\n* Posted for elective surgery requiring general anesthesia and tracheal intubation\n\nExclusion Criteria:\n\n* patients with anticipated difficult airway\n* obese (body mass index (BMI)\\>30) patients\n* patients with risk of pulmonary aspiration of gastric contents\n* pregnant patients\n* patients with airway distortion or trauma.'}, 'identificationModule': {'nctId': 'NCT02387502', 'briefTitle': 'Comparison of Three Laryngoscopes in Difficult Laryngoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Government Medical College, Haldwani'}, 'officialTitle': 'Comparative Evaluation of Macintosh, MacCoy and Airtraq Laryngoscope in Simulated Difficult Laryngoscopy Using Rigid Neck Collar', 'orgStudyIdInfo': {'id': '123-IEC/01/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intubation with Macintosh laryngoscope', 'description': '40 patients were intubated with Macintosh laryngoscope after simulating difficult laryngoscopy using rigid neck collar.', 'interventionNames': ['Device: Intubation- Macintosh laryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intubation with MacCoy laryngoscope', 'description': '40 patients were intubated with MacCoy laryngoscope after simulating difficult laryngoscopy using rigid neck collar.', 'interventionNames': ['Device: Intubation- MacCoy laryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intubation with Airtraq laryngoscope', 'description': '40 patients were intubated with Airtraq laryngoscope after simulating difficult laryngoscopy using rigid neck collar.', 'interventionNames': ['Device: Intubation- Airtraq laryngoscope']}], 'interventions': [{'name': 'Intubation- Macintosh laryngoscope', 'type': 'DEVICE', 'description': 'Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.', 'armGroupLabels': ['Intubation with Macintosh laryngoscope']}, {'name': 'Intubation- MacCoy laryngoscope', 'type': 'DEVICE', 'description': 'In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.', 'armGroupLabels': ['Intubation with MacCoy laryngoscope']}, {'name': 'Intubation- Airtraq laryngoscope', 'type': 'DEVICE', 'description': 'In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.', 'armGroupLabels': ['Intubation with Airtraq laryngoscope']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Geeta Bhandari, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor, Department of Anesthesiology, G.M.C. Haldwani'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Medical College, Haldwani', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Bikramjit Das', 'investigatorAffiliation': 'Government Medical College, Haldwani'}}}}