Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT03955094
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2019-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ambu® Auragain™ as a Conduit for Intubation in Paediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective observational study All eligible patients will be approached and recruited All patients will be assigned to a single group - the use of AMBU® AURAGAIN™ as a conduit for flexible scope intubation No comparison groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-03', 'studyFirstSubmitDate': '2019-05-08', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time required for insertion of Ambu® AuraGain™', 'timeFrame': 'Time taken during procedure ( measured in seconds )', 'description': 'Device insertion is limited to two attempts'}, {'measure': 'Determine oropharyngeal leak pressure of Ambu® AuraGain™', 'timeFrame': 'Immediately post procedure- insertion of Ambu® AuraGain™ ( measured in mmHg )', 'description': 'Standard oropharyngeal leak test performed'}], 'primaryOutcomes': [{'measure': 'Time taken to successful intubation via the Ambu® AuraGain™', 'timeFrame': 'Time taken during procedure ( measured in seconds )', 'description': 'Successful intubation is confirmed via the equal air entry heard bilaterally on auscultation and a positive capnograph tracing'}], 'secondaryOutcomes': [{'measure': 'Time taken required for removal of Ambu® AuraGain™ post intubation', 'timeFrame': 'Time taken during procedure ( measured in seconds )', 'description': 'Successful removal of device is confirmed by equal air entry heard bilaterally on auscultation and a positive capnograph tracing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AMBU® AURAGAIN™', 'intubation in paediatrics', 'flexible scope guided intubation', 'success rate of intubation', 'glottic view', 'supraglottic airway intubation', 'efficacy safety'], 'conditions': ['Pediatric Endotracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '21973052', 'type': 'BACKGROUND', 'citation': 'Sinha R, Chandralekha, Ray BR. Evaluation of air-Q intubating laryngeal airway as a conduit for tracheal intubation in infants--a pilot study. Paediatr Anaesth. 2012 Feb;22(2):156-60. doi: 10.1111/j.1460-9592.2011.03710.x.'}, {'pmid': '26417722', 'type': 'BACKGROUND', 'citation': 'Pandey RK, Subramanium RK, Darlong V, Lekha C, Garg R, Punj J, Rewari V, Bajpai M. Evaluation of glottic view through Air-Q Intubating Laryngeal Airway in the supine and lateral position and assessing it as a conduit for blind endotracheal intubation in children in the supine position. Paediatr Anaesth. 2015 Dec;25(12):1241-7. doi: 10.1111/pan.12746. Epub 2015 Sep 29.'}, {'pmid': '21081777', 'type': 'BACKGROUND', 'citation': 'Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16.'}, {'pmid': '22971118', 'type': 'BACKGROUND', 'citation': 'Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Shah RD, Mukherji II, Roth AG, Suresh S. A randomized trial comparing the Ambu (R) Aura-i with the air-Q intubating laryngeal airway as conduits for tracheal intubation in children. Paediatr Anaesth. 2012 Dec;22(12):1197-204. doi: 10.1111/pan.12024. Epub 2012 Sep 13.'}, {'pmid': '25537736', 'type': 'BACKGROUND', 'citation': 'Jagannathan N, Sohn L, Ramsey M, Huang A, Sawardekar A, Sequera-Ramos L, Kromrey L, De Oliveira GS. A randomized comparison between the i-gel and the air-Q supraglottic airways when used by anesthesiology trainees as conduits for tracheal intubation in children. Can J Anaesth. 2015 Jun;62(6):587-94. doi: 10.1007/s12630-014-0304-9. Epub 2014 Dec 24.'}, {'pmid': '25422603', 'type': 'BACKGROUND', 'citation': 'Girgis KK, Youssef MM, ElZayyat NS. Comparison of the air-Q intubating laryngeal airway and the cobra perilaryngeal airway as conduits for fiber optic-guided intubation in pediatric patients. Saudi J Anaesth. 2014 Oct;8(4):470-6. doi: 10.4103/1658-354X.140841.'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted as a prospective observational study\n\nThis study will be done in any of the operating theatres of University Malaya Medical Centre\n\nThis study will involve paediatric cases ( ages 3-12 years )posted for elective operations which require general anaesthesia with endotracheal intubation\n\nAmbu Aura Gain will be used as a conduit for intubation', 'detailedDescription': 'All eligible participants will be approached and recruited Informed consent will be obtained Induction of general anesthesia will be as per usual standardized method Ambu® Auragain™ will be inserted A paediatric flexible endoscope will be used to view the glottis and railroad an endotracheal tube into the trachea Placement is confirmed and number of attempts and time required for successful intubation is recorded Ambu® Auragain™ will be removed Number of attempts and time taken for removal of Ambu® Auragain™ will be recorded Any complications will be noted and recorded'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Paediatric patients aged 3 - 12 years old\n* American Society of Anaesthesiologist (ASA) 1-2 patients\n* Patients must require standard endotracheal intubation for the procedure posted\n\nExclusion Criteria:\n\n* Documented history of difficult airway in previous general anaesthesia\n* Clinical features of difficult airway on physical examination\n* Syndromic patients, facial deformities, dental deformities, patients with facial trauma\n* Patients with recent (less than 2 weeks) or ongoing upper respiratory tract infection\n* Patients with existing pulmonary diseases or any risk of bronchospasm\n* Patients with known gastric outlet obstruction, reflux disease, or any risk of aspiration\n* Any other contraindication for device placement\n* Operations requiring specialised endotracheal tubes\n* Emergency operations or unanticipated difficult airway cases\n* Refusal of parental informed consent'}, 'identificationModule': {'nctId': 'NCT03955094', 'briefTitle': 'Ambu® Auragain™ as a Conduit for Intubation in Paediatrics', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Clinical Evaluation of Ambu® Auragain™ as a Conduit for Intubation in Paediatrics', 'orgStudyIdInfo': {'id': 'Auragain study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMBU® AURAGAIN™ device', 'description': 'Assess feasibility of AMBU® AURAGAIN™ as an intubating device in paediatrics', 'interventionNames': ['Device: Intubation via AMBU® AURAGAIN™']}], 'interventions': [{'name': 'Intubation via AMBU® AURAGAIN™', 'type': 'DEVICE', 'otherNames': ['AMBU® AURAGAIN™', 'Supraglottic device'], 'description': 'Success rate of paediatric intubation through AMBU® AURAGAIN™', 'armGroupLabels': ['AMBU® AURAGAIN™ device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University of Malaya', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'Ismiarti S Ina, MAnaes(UM)', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical officer UD 48', 'investigatorFullName': 'Dr Lim Su Sian', 'investigatorAffiliation': 'University of Malaya'}}}}