Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT02566135
Status:
COMPLETED
Last Update Posted:
2018-07-27
First Post:
2015-09-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dhimaraditi@yahoo.in', 'phone': '09825334605', 'title': 'Dr Aditi Amrutlal Dhimar', 'organization': 'Medical College, Baroda.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The use of fiber optic bronchoscope for confirmation of proper placement of I-gel and C-LMA would have been better. Also One can see the passage of ventilating bougie through I-gel and C-LMA into larynx and trachea.'}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Group-I', 'description': "In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube.", 'otherNumAtRisk': 29, 'otherNumAffected': 2, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group-C', 'description': "In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube.", 'otherNumAtRisk': 29, 'otherNumAffected': 4, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Airway trauma', 'notes': 'Trauma to tongue, lips, teeth, pharyngeal tissue etc.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tube impingement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Attempts for I-gel or Classic-LMA Insertions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-I', 'description': "In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."}, {'id': 'OG001', 'title': 'Group-C', 'description': "In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."}], 'classes': [{'title': '1st attempt', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': '2nd attempt', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '3rd attempt', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4628', 'ciLowerLimit': '0.6401', 'ciUpperLimit': '3.3428', 'groupDescription': 'Chi square test was applied to see weather there is a statistical significant difference between group I and group C for attempt for supraglottic airway insertion.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '60 seconds', 'unitOfMeasure': 'attempt', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-I', 'description': "In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."}, {'id': 'OG001', 'title': 'Group-C', 'description': "In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."}], 'classes': [{'title': '1st attempt', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': '2nd attempt', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '3rd attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8972', 'ciLowerLimit': '0.4858', 'ciUpperLimit': '1.6569', 'groupDescription': 'We had applied chi square to see the statistical significant difference between group I and group C for number of attempt for ventilating bougie insertion.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '45 seconds', 'unitOfMeasure': 'attempt', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-I', 'description': "In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."}, {'id': 'OG001', 'title': 'Group-C', 'description': "In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."}], 'classes': [{'title': '1st attempt', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': '2nd attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '3rd attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 seconds', 'unitOfMeasure': 'attempt', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-I', 'description': "In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."}, {'id': 'OG001', 'title': 'Group-C', 'description': "In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '91.06', 'spread': '11.72', 'groupId': 'OG000'}, {'value': '88.89', 'spread': '9.76', 'groupId': 'OG001'}]}]}, {'title': 'After Dex injection', 'categories': [{'measurements': [{'value': '71.24', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '72.75', 'spread': '10.76', 'groupId': 'OG001'}]}]}, {'title': 'After induction', 'categories': [{'measurements': [{'value': '69.87', 'spread': '11.81', 'groupId': 'OG000'}, {'value': '74.1', 'spread': '11.17', 'groupId': 'OG001'}]}]}, {'title': 'SGA insertion', 'categories': [{'measurements': [{'value': '75.68', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '78.79', 'spread': '9.73', 'groupId': 'OG001'}]}]}, {'title': 'V. Bougie insertion', 'categories': [{'measurements': [{'value': '85.55', 'spread': '6.60', 'groupId': 'OG000'}, {'value': '82.41', 'spread': '5.78', 'groupId': 'OG001'}]}]}, {'title': 'ETT insertion', 'categories': [{'measurements': [{'value': '83.27', 'spread': '9.75', 'groupId': 'OG000'}, {'value': '81.65', 'spread': '5.94', 'groupId': 'OG001'}]}]}, {'title': '3 min after ETT insertion', 'categories': [{'measurements': [{'value': '83.75', 'spread': '8.78', 'groupId': 'OG000'}, {'value': '82.72', 'spread': '7.65', 'groupId': 'OG001'}]}]}, {'title': '5 min after ETT insertion', 'categories': [{'measurements': [{'value': '81.17', 'spread': '6.99', 'groupId': 'OG000'}, {'value': '79', 'spread': '8.62', 'groupId': 'OG001'}]}]}, {'title': '7 min after ETT insertion', 'categories': [{'measurements': [{'value': '81.86', 'spread': '7.01', 'groupId': 'OG000'}, {'value': '79.34', 'spread': '7.31', 'groupId': 'OG001'}]}]}, {'title': '10 min after ETT insertion', 'categories': [{'measurements': [{'value': '80.86', 'spread': '6.53', 'groupId': 'OG000'}, {'value': '78.79', 'spread': '6.39', 'groupId': 'OG001'}]}]}, {'title': '15 min after ETT insertion', 'categories': [{'measurements': [{'value': '81.13', 'spread': '5.87', 'groupId': 'OG000'}, {'value': '78.41', 'spread': '8.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Heart rate beats per minute measured at base line among the group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Heart rate beats per minute is measured following Dexmedetomidine injection among the group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Heart rate beats per minute measured following induction of anaesthesia among the group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Heart rate beats per minute measured following supraglottic airway insertion among the group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.059', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Heart rate beats per minute measured following ventilating bougie insertion among the group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '>0.33', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Heart rate beats per minute measured at endotracheal intubation among the group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Heart rate beats per minute measured after 3 minute of ETT insertion among the group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Heart rate beats per minute measured after 5 minute of ETT insertion among the group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Heart rate beats per minute measured after 7 minute of ETT insertion among the group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.98', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Heart rate beats per minute measured after 10 minute of ETT insertion among the group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Heart rate beats per minute measured after 15 minute of ETT insertion among the group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '25 minutes', 'description': 'Heart rate to observe at the following time intervals.\n\n1. Base line\n2. After induction\n3. After dexmedetomidine injection\n4. Supraglottic airway insertion\n5. Ventilating bougie insertion\n6. ETT insertion\n7. 3minute after ETT insertion\n8. 5 minute after ETT insertion\n9. 7 minute after ETT insertion\n10. 10 minute after ETT insertion\n11. 15 minute after ETT insertion Study period is upto 15 minutes, thereafter the study ends here.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-I', 'description': "In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."}, {'id': 'OG001', 'title': 'Group-C', 'description': "In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '122.31', 'spread': '8.07', 'groupId': 'OG000'}, {'value': '125.31', 'spread': '11.06', 'groupId': 'OG001'}]}]}, {'title': 'After Dex injection', 'categories': [{'measurements': [{'value': '109.96', 'spread': '8.15', 'groupId': 'OG000'}, {'value': '114.34', 'spread': '12.41', 'groupId': 'OG001'}]}]}, {'title': 'After induction', 'categories': [{'measurements': [{'value': '108.03', 'spread': '8.34', 'groupId': 'OG000'}, {'value': '112.51', 'spread': '10.53', 'groupId': 'OG001'}]}]}, {'title': 'SGA insertion', 'categories': [{'measurements': [{'value': '113.93', 'spread': '6.14', 'groupId': 'OG000'}, {'value': '114.24', 'spread': '6.62', 'groupId': 'OG001'}]}]}, {'title': 'V. Bougie insertion', 'categories': [{'measurements': [{'value': '118.65', 'spread': '5.17', 'groupId': 'OG000'}, {'value': '116.10', 'spread': '4.73', 'groupId': 'OG001'}]}]}, {'title': 'ETT insertion', 'categories': [{'measurements': [{'value': '117.37', 'spread': '4.87', 'groupId': 'OG000'}, {'value': '117.93', 'spread': '6.70', 'groupId': 'OG001'}]}]}, {'title': '3 min after ETT insertion', 'categories': [{'measurements': [{'value': '116.03', 'spread': '4.91', 'groupId': 'OG000'}, {'value': '118.31', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': '5 min after ETT insertion', 'categories': [{'measurements': [{'value': '118.62', 'spread': '5.36', 'groupId': 'OG000'}, {'value': '118.31', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': '7 min after ETT insertion', 'categories': [{'measurements': [{'value': '115.13', 'spread': '5.35', 'groupId': 'OG000'}, {'value': '115.79', 'spread': '6.95', 'groupId': 'OG001'}]}]}, {'title': '10 min after ETT insertion', 'categories': [{'measurements': [{'value': '116.93', 'spread': '6.55', 'groupId': 'OG000'}, {'value': '116.96', 'spread': '10.95', 'groupId': 'OG001'}]}]}, {'title': '15 min after ETT insertion', 'categories': [{'measurements': [{'value': '116.62', 'spread': '6.61', 'groupId': 'OG000'}, {'value': '118.1', 'spread': '9.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Systolic blood pressure measured and compared at base line between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Systolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Systolic blood pressure measured and compared following induction os anaesthesia between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Systolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Systolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Systolic blood pressure measured and compared at ETT insertion time between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Systolic blood pressure measured and compared 3 minutes after ETT insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Systolic blood pressure measured and compared 5 minutes after ETT insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Systolic blood pressure measured and compared 7 minutes after ETT insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.98', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Systolic blood pressure measured and compared 10 minutes after ETT insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Systolic blood pressure measured and compared 15 minutes after ETT insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '25 minutes', 'description': 'Systolic blood pressure measured at following time intervals.\n\n1. Base line\n2. After Dexmedetomidine injection\n3. After induction of anaesthesia\n4. Supraglottic airway insertion\n5. Ventilating bougie insertion\n6. ETT insertion\n7. 3 minute after ETT insertion\n8. 5 minute after ETT insertion\n9. 7 minute after ETT insertion\n10. 10 minute after ETT insertion\n11. 15 minute after ETT insertion. The study period was upto 15 minutes and thereafter the study ends.', 'unitOfMeasure': 'mmhg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-I', 'description': "In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."}, {'id': 'OG001', 'title': 'Group-C', 'description': "In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '79.96', 'spread': '5.88', 'groupId': 'OG000'}, {'value': '81.51', 'spread': '6.57', 'groupId': 'OG001'}]}]}, {'title': 'After Dex injection', 'categories': [{'measurements': [{'value': '71.24', 'spread': '7.67', 'groupId': 'OG000'}, {'value': '73.68', 'spread': '9.03', 'groupId': 'OG001'}]}]}, {'title': 'After induction', 'categories': [{'measurements': [{'value': '70.1', 'spread': '7.99', 'groupId': 'OG000'}, {'value': '72.79', 'spread': '8.64', 'groupId': 'OG001'}]}]}, {'title': 'SGA insertion', 'categories': [{'measurements': [{'value': '75.24', 'spread': '5.13', 'groupId': 'OG000'}, {'value': '75.17', 'spread': '8.37', 'groupId': 'OG001'}]}]}, {'title': 'V. Bougie insertion', 'categories': [{'measurements': [{'value': '77.03', 'spread': '4.22', 'groupId': 'OG000'}, {'value': '76.51', 'spread': '6.40', 'groupId': 'OG001'}]}]}, {'title': 'ETT insertion', 'categories': [{'measurements': [{'value': '76.51', 'spread': '5.19', 'groupId': 'OG000'}, {'value': '75.68', 'spread': '5.50', 'groupId': 'OG001'}]}]}, {'title': '3 min after ETT insertion', 'categories': [{'measurements': [{'value': '76.24', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '75.34', 'spread': '5.72', 'groupId': 'OG001'}]}]}, {'title': '5 min after ETT insertion', 'categories': [{'measurements': [{'value': '76.03', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '75.03', 'spread': '6.57', 'groupId': 'OG001'}]}]}, {'title': '7 min after ETT insertion', 'categories': [{'measurements': [{'value': '76.1', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '75.72', 'spread': '5.22', 'groupId': 'OG001'}]}]}, {'title': '10 min after ETT insertion', 'categories': [{'measurements': [{'value': '77.37', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '76.79', 'spread': '6.96', 'groupId': 'OG001'}]}]}, {'title': '15 min after ETT insertion', 'categories': [{'measurements': [{'value': '77.1', 'spread': '4.35', 'groupId': 'OG000'}, {'value': '76.79', 'spread': '5.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Diastolic blood pressure measured and compared at base line between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Diastolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Diastolic blood pressure measured and compared following induction of anaesrthesia between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Diastolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Diastolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Diastolic blood pressure measured and compared the time of endotracheal tube insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Diastolic blood pressure measured and compared 3 minutes after endotracheal tube insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Diastolic blood pressure measured and compared 5 minutes after endotracheal tube insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Diastolic blood pressure measured and compared 7 minutes after endotracheal tube insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Diastolic blood pressure measured and compared 10 minutes after endotracheal tube insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Diastolic blood pressure measured and compared 15 minutes after endotracheal tube insertion between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '25 minutes', 'description': 'Diastolic blood pressure measured at following time intervals.\n\n1. Base line\n2. After Dexmedetomidine injection\n3. After Induction\n4. Supraglottic airway insertion\n5. Ventilating bougie insertion\n6. ETT insertion\n7. 3 minute after ETT insertion\n8. 5 minute after ETT insertion\n9. 7 minute after ETT insertion\n10. 10 minutes after ETT insertion\n11. 15 minute after ETT insertion The study period was upto 15 minutes. thereafter study ends.', 'unitOfMeasure': 'mmhg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time of Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-I', 'description': "In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."}, {'id': 'OG001', 'title': 'Group-C', 'description': "In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."}], 'classes': [{'title': 'Supraglottic airway', 'categories': [{'measurements': [{'value': '26.17', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '44.65', 'spread': '9.14', 'groupId': 'OG001'}]}]}, {'title': 'Ventilating bougie', 'categories': [{'measurements': [{'value': '31.51', 'spread': '8.87', 'groupId': 'OG000'}, {'value': '26.31', 'spread': '9.25', 'groupId': 'OG001'}]}]}, {'title': 'ETT', 'categories': [{'measurements': [{'value': '25.58', 'spread': '4.01', 'groupId': 'OG000'}, {'value': '28.13', 'spread': '8.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'We had compared time of insertion for supraglottic airway between group I and group C.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '5 minutes', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Intubation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-I', 'description': "In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."}, {'id': 'OG001', 'title': 'Group-C', 'description': "In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."}], 'classes': [{'categories': [{'measurements': [{'value': '93.27', 'spread': '9.03', 'groupId': 'OG000'}, {'value': '108.96', 'spread': '16.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '5 minutes', 'unitOfMeasure': 'Second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group-I', 'description': "In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."}, {'id': 'FG001', 'title': 'Group-C', 'description': "In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group-I', 'description': "In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube."}, {'id': 'BG001', 'title': 'Group-C', 'description': "In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie.\n\nTracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube."}, {'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': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', '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': '35.03', 'spread': '10.13', 'groupId': 'BG000'}, {'value': '36.13', 'spread': '11.24', 'groupId': 'BG001'}, {'value': '35.58', 'spread': '10.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "ASAPS ( American society of Anaesthesiologist's physical ststus", 'classes': [{'title': 'ASAPS I', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'ASAPS II', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ASA I:\n\nA normal healthy patient Healthy, non-smoking, no or minimal alcohol use\n\nASA II:\n\nA patient with mild systemic disease Mild diseases only without substantive functional limitations.\n\nASA III:\n\nA patient with severe systemic disease Substantive functional limitations; One or more moderate to severe diseases.\n\nASA IV:\n\nA patient with severe systemic disease that is a constant threat to life\n\nASA V:\n\nA moribund patient who is not expected to survive without the operation\n\nASA VI:\n\nA declared brain-dead patient whose organs are being removed for donor purposes', 'unitOfMeasure': 'participants'}, {'title': 'BMI (body mass index)', 'classes': [{'categories': [{'measurements': [{'value': '21.30', 'spread': '2.96', 'groupId': 'BG000'}, {'value': '21.43', 'spread': '2.19', 'groupId': 'BG001'}, {'value': '21.36', 'spread': '2.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-26', 'studyFirstSubmitDate': '2015-09-07', 'resultsFirstSubmitDate': '2015-11-22', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-26', 'studyFirstPostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Attempts for I-gel or Classic-LMA Insertions', 'timeFrame': '60 seconds'}, {'measure': 'Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA', 'timeFrame': '45 seconds'}, {'measure': 'Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie', 'timeFrame': '30 seconds'}, {'measure': 'Time of Insertion', 'timeFrame': '5 minutes'}, {'measure': 'Total Intubation Time', 'timeFrame': '5 minutes'}], 'secondaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': '25 minutes', 'description': 'Heart rate to observe at the following time intervals.\n\n1. Base line\n2. After induction\n3. After dexmedetomidine injection\n4. Supraglottic airway insertion\n5. Ventilating bougie insertion\n6. ETT insertion\n7. 3minute after ETT insertion\n8. 5 minute after ETT insertion\n9. 7 minute after ETT insertion\n10. 10 minute after ETT insertion\n11. 15 minute after ETT insertion Study period is upto 15 minutes, thereafter the study ends here.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '25 minutes', 'description': 'Systolic blood pressure measured at following time intervals.\n\n1. Base line\n2. After Dexmedetomidine injection\n3. After induction of anaesthesia\n4. Supraglottic airway insertion\n5. Ventilating bougie insertion\n6. ETT insertion\n7. 3 minute after ETT insertion\n8. 5 minute after ETT insertion\n9. 7 minute after ETT insertion\n10. 10 minute after ETT insertion\n11. 15 minute after ETT insertion. The study period was upto 15 minutes and thereafter the study ends.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '25 minutes', 'description': 'Diastolic blood pressure measured at following time intervals.\n\n1. Base line\n2. After Dexmedetomidine injection\n3. After Induction\n4. Supraglottic airway insertion\n5. Ventilating bougie insertion\n6. ETT insertion\n7. 3 minute after ETT insertion\n8. 5 minute after ETT insertion\n9. 7 minute after ETT insertion\n10. 10 minutes after ETT insertion\n11. 15 minute after ETT insertion The study period was upto 15 minutes. thereafter study ends.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['C-LMA', 'I-gel', 'ventilating bougie', 'intubation'], 'conditions': ['Intubation; Difficult']}, 'referencesModule': {'references': [{'pmid': '25197106', 'type': 'BACKGROUND', 'citation': 'Kapoor S, Jethava DD, Gupta P, Jethava D, Kumar A. Comparison of supraglottic devices i-gel((R)) and LMA Fastrach((R)) as conduit for endotracheal intubation. Indian J Anaesth. 2014 Jul;58(4):397-402. doi: 10.4103/0019-5049.138969.'}, {'pmid': '22653838', 'type': 'RESULT', 'citation': 'Wong DT, Yang JJ, Mak HY, Jagannathan N. Use of intubation introducers through a supraglottic airway to facilitate tracheal intubation: a brief review. Can J Anaesth. 2012 Jul;59(7):704-15. doi: 10.1007/s12630-012-9714-8. Epub 2012 Jun 1.'}, {'pmid': '23087456', 'type': 'RESULT', 'citation': 'Singh J, Yadav MK, Marahatta SB, Shrestha BL. Randomized crossover comparison of the laryngeal mask airway classic with i-gel laryngeal mask airway in the management of difficult airway in post burn neck contracture patients. Indian J Anaesth. 2012 Jul;56(4):348-52. doi: 10.4103/0019-5049.100815.'}]}, 'descriptionModule': {'briefSummary': 'Supraglottic Airway devices(SGAs) like I-Gel and C-LMA ( classic laryngeal mask airway ) have been used as a conduit for tracheal intubation using ventilating bougie. General Anaesthesia with tracheal intubation is one of the technique for giving anaesthesia. Tracheal intubation may become difficult sometimes and endangers patients life. Using SGAs as a conduit for tracheal intubation helps in securing airway. This will be further facilitated by using ventilating bougie, as it maintains oxygenation.', 'detailedDescription': "SGAs have been used as a conduit for tracheal intubation using ventilating bougie. Patients were anaesthetised with intravenous induction agent, non-depolarising muscle relaxant and then SGAs were inserted. Two groups were compared. In group I : I-gel was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then I-gel was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed. In group C : C-LMA was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then C-LMA was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 18 to 60 years\n* Gender : either sex\n* American society of Anaesthesiologist's Physical Status (ASAPS) I and II\n* Patients posted for surgery requiring general anaesthesia and endotracheal intubation.\n\nExclusion Criteria:\n\n* age \\<18 years and \\> 60 years\n* ASAPS III or IV\n* Obesity body mass index \\>25\n* Patients with mouth opening \\<2cms\n* Patients with Malampatti grade III and IV\n* Patients having history of gastro-esophageal reflux disease\n* Patients with history of inadequate fasting\n* Patients with known or anticipated difficult tracheal intubation or face-mask ventilation."}, 'identificationModule': {'nctId': 'NCT02566135', 'briefTitle': 'I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie', 'organization': {'class': 'OTHER', 'fullName': 'Medical College Baroda'}, 'officialTitle': 'I-gel Versus C-LMA as a Conduit for Tracheal Intubation Using Ventilating Bougie', 'orgStudyIdInfo': {'id': 'ECR/85/Inst/GJ/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group-I', 'description': 'Tracheal intubation using I-gel and ventilating bougie insertion. In Group-I, following general anaesthesia I-gel is to be inserted, through it ventilating bougie is to be inserted then I-gel is to be removed and endotracheal tube is to be railroaded over ventilating bougie. Then ventilating bougie is to be removed.', 'interventionNames': ['Device: Tracheal Intubation using I-gel and ventilating bougie']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group-C', 'description': 'Tracheal intubation using C-LMA and ventilating bougie insertion. In Group-C, following general anaesthesia C-LMA is to be inserted, through it ventilating bougie is to be inserted then C-LMA is to be removed and endotracheal tube is to be railroaded over ventilating bougie. Then ventilating bougie is to be removed.', 'interventionNames': ['Device: Tracheal Intubation using C-LMA and ventilating bougie']}], 'interventions': [{'name': 'Tracheal Intubation using I-gel and ventilating bougie', 'type': 'DEVICE', 'description': "Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube.", 'armGroupLabels': ['Group-I']}, {'name': 'Tracheal Intubation using C-LMA and ventilating bougie', 'type': 'DEVICE', 'description': "Following general anaesthesia C-LMA was inserted. After proper placement of C-LMA, ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube.", 'armGroupLabels': ['Group-C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Aditi A Dhimar, M.D.(anaes)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CDSCO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College Baroda', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR ADITI AMRUTLAL DHIMAR', 'investigatorFullName': 'DR ADITI AMRUTLAL DHIMAR', 'investigatorAffiliation': 'Medical College Baroda'}}}}