Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-27 @ 7:26 AM
Study NCT ID:
NCT02380768
Status:
COMPLETED
Last Update Posted:
2015-07-20
First Post:
2015-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of the Ambu AuraGain Versus LMA Supreme in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-17', 'studyFirstSubmitDate': '2015-02-26', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oropharyngeal (airway) leak pressure - Initial', 'timeFrame': 'Assessed intraoperatively at the time of confirmed device placement', 'description': 'The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway'}, {'measure': 'Oropharyngeal (airway) leak pressure - 10 Minutes', 'timeFrame': 'Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device', 'description': 'The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway'}], 'secondaryOutcomes': [{'measure': 'Time for Successful Placement of the Supraglottic Airway', 'timeFrame': 'Assessed intraoperatively at the time of confirmed device placement', 'description': 'Time for successful placement of supraglottic device will be recorded'}, {'measure': 'Number of attempts to placement of Supraglottic Airway', 'timeFrame': 'Assessed intraoperatively at the time of confirmed device placement', 'description': 'Number of attempts and insertion techniques will be recorded (maximum of 3 attempts)'}, {'measure': 'Fiberoptic Grade of Laryngeal View through Supraglottic Airway', 'timeFrame': 'Assessed intraoperatively at the time of confirmed device placement', 'description': 'Fiberoptic Grade of Laryngeal View through either device will be graded using a previously published grading system'}, {'measure': 'Gastric Tube Insertion Ease of Placement', 'timeFrame': 'Assessed intraoperatively at the time of confirmed gastric tube placement', 'description': 'The ease of placement, based on a 1-4 scale, will be recorded following placement and confirmation of the gastric tube.'}, {'measure': 'Gastric Tube Insertion Time', 'timeFrame': 'Assessed intraoperatively at the time of confirmed gastric tube placement', 'description': 'The elapsed time from beginning insertion of the gastric tube to confirmation, will be recorded. Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.'}, {'measure': 'Gastric Tube Insertion Attempts', 'timeFrame': 'Assessed intraoperatively at the time of confirmed gastric tube placement', 'description': 'Number of insertion attempts of the gastric tube through the SGA will be recorded. Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.'}, {'measure': 'Postoperative Complications', 'timeFrame': 'Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.', 'description': 'Patient will be evaluated for sore throat, cough, dysphonia, stridor, or other airway related complications during the post-operative period.'}, {'measure': 'Intraoperative Complications', 'timeFrame': 'Assessed intraoperatively', 'description': 'Complications such as reflex activation of the airway (coughing, breath holding, laryngospasm, bronchospasm), oxygen desaturation will be recorded, if they occur.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Supraglottic airway', 'Laryngeal mask airway', 'Children'], 'conditions': ['Supraglottic Airway']}, 'referencesModule': {'references': [{'pmid': '19572845', 'type': 'BACKGROUND', 'citation': 'White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x.'}, {'pmid': '25585975', 'type': 'BACKGROUND', 'citation': 'Jagannathan N, Ramsey MA, White MC, Sohn L. An update on newer pediatric supraglottic airways with recommendations for clinical use. Paediatr Anaesth. 2015 Apr;25(4):334-45. doi: 10.1111/pan.12614. Epub 2015 Jan 13.'}, {'pmid': '22420717', 'type': 'BACKGROUND', 'citation': 'Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Langen KE, Anderson K. A randomised comparison of the LMA SupremeTM and LMAProSealTM in children. Anaesthesia. 2012 Jun;67(6):632-9. doi: 10.1111/j.1365-2044.2012.07088.x. Epub 2012 Mar 15.'}, {'pmid': '23521105', 'type': 'BACKGROUND', 'citation': 'Jagannathan N, Sohn L, Sommers K, Belvis D, Shah RD, Sawardekar A, Eidem J, Dagraca J, Mukherji I. A randomized comparison of the laryngeal mask airway supreme and laryngeal mask airway unique in infants and children: does cuff pressure influence leak pressure? Paediatr Anaesth. 2013 Oct;23(10):927-33. doi: 10.1111/pan.12145. Epub 2013 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.', 'detailedDescription': 'The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain (sizes 1.5 and 2) and the Laryngeal Mask Airway (LMA) Supreme. Parameters of clinical relevance such as insertion success rates, fiberoptic view of the glottic opening, ease and speed of gastric tube placement, airway stability, and peri-operative complications will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for surgery utilizing a supraglottic airway device\n* ASA (American Society of Anesthesiologists) I-III classification\n* Weighing between 5 - 20 kilograms\n\nExclusion Criteria:\n\n* Active respiratory infection\n* History of difficult mask ventilation\n* Diagnosis of congenital syndrome with difficult airway management\n* Active gastrointestinal reflux\n* Coagulopathy\n* Significant Pulmonary disease\n* Emergent surgery'}, 'identificationModule': {'nctId': 'NCT02380768', 'briefTitle': 'A Comparison of the Ambu AuraGain Versus LMA Supreme in Children', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'A Randomized Comparison of the Ambu AuraGain™ and LMA Supreme™ in Infants and Children', 'orgStudyIdInfo': {'id': 'IRB 2015-252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ambu AuraGain', 'description': 'Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines', 'interventionNames': ['Device: Ambu AuraGain (size 1.5 or size 2.0)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LMA Supreme', 'description': 'Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines', 'interventionNames': ['Device: LMA Supreme (size 1.5 or size 2.0)']}], 'interventions': [{'name': 'Ambu AuraGain (size 1.5 or size 2.0)', 'type': 'DEVICE', 'otherNames': ['Ambu AuraGain'], 'description': 'The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.', 'armGroupLabels': ['Ambu AuraGain']}, {'name': 'LMA Supreme (size 1.5 or size 2.0)', 'type': 'DEVICE', 'otherNames': ['LMA Supreme'], 'description': 'The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.', 'armGroupLabels': ['LMA Supreme']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Narasimhan Jagannathan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator; M.D.', 'investigatorFullName': 'Narasimhan Jagannathan', 'investigatorAffiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}}