Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
Study NCT ID:
NCT04501068
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2020-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Ambu® AuraGain in Ambulatory Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-05', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the number of attempts to insert the Ambu® AuraGainTM supraglottic airway', 'timeFrame': 'The number of insertion attempts will be collected after anesthesia induction', 'description': 'Insertion attempts (in numbers)\n\nFrom picking up the Ambu® AuraGainTM supraglottic airway until the mask is placed into the patient mouth. (in numbers)'}, {'measure': 'Evaluate the time to insert the Ambu® AuraGainTM supraglottic airway', 'timeFrame': 'The insertion time will be collected after anesthesia induction after administration of propofol', 'description': 'The time from picking up the Ambu® AuraGainTM supraglottic airway until the cuff was inflated. (in seconds)'}], 'secondaryOutcomes': [{'measure': 'Blood pressure during insertion of the Ambu® AuraGainTM supraglottic airway', 'timeFrame': 'At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway', 'description': 'Blood pressure in mmHg'}, {'measure': 'Heart rate during insertion of the Ambu® AuraGainTM supraglottic airway heart rate', 'timeFrame': 'At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway]', 'description': 'Heart rate in beep per minute'}, {'measure': 'BIS data', 'timeFrame': 'At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway (To evaluate the evolution of BIS values during insertion of the Ambu® AuraGainTM supraglottic airway', 'description': 'Bis data: number from 100 (awake) to 40-45 (anesthetic status)'}, {'measure': 'Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway.', 'timeFrame': 'The Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway will be collected 10 minutes after the Ambu® AuraGainTM supraglottic airway will be inserted]', 'description': 'The Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway will be determined with an intracuff pressure of 60 cm H2O by closing the expiratory valve of the breathing circle circuit at a fixed gas flow of 3 L/min and noting the pressure at which an oropharyngeal leak occurs. (in cm H2O)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ambu® AuraGainTM', 'Second Generation Laryngeal Masks Airway'], 'conditions': ['Airway']}, 'referencesModule': {'references': [{'pmid': '28267947', 'type': 'RESULT', 'citation': 'Shariffuddin II, Teoh WH, Tang E, Hashim N, Loh PS. Ambu(R) AuraGain versus LMA Supreme Second Seal: a randomised controlled trial comparing oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients. Anaesth Intensive Care. 2017 Mar;45(2):244-250. doi: 10.1177/0310057X1704500215.'}, {'pmid': '29582360', 'type': 'RESULT', 'citation': 'Wong DT, Ooi A, Singh KP, Dallaire A, Meliana V, Lau J, Chung F, Singh M, Wong J. Comparison of oropharyngeal leak pressure between the Ambu(R) AuraGain and the LMA(R) Supreme supraglottic airways: a randomized-controlled trial. Can J Anaesth. 2018 Jul;65(7):797-805. doi: 10.1007/s12630-018-1120-4. Epub 2018 Mar 26.'}, {'pmid': '27889843', 'type': 'RESULT', 'citation': 'Lopez AM, Agusti M, Gambus P, Pons M, Anglada T, Valero R. A randomized comparison of the Ambu AuraGain versus the LMA supreme in patients undergoing gynaecologic laparoscopic surgery. J Clin Monit Comput. 2017 Dec;31(6):1255-1262. doi: 10.1007/s10877-016-9963-0. Epub 2016 Nov 26.'}, {'pmid': '30189821', 'type': 'RESULT', 'citation': 'Preece G, Ng I, Lee K, Mezzavia P, Krieser R, Williams DL, Stewart O, Segal R. A randomised controlled trial comparing fibreoptic-guided tracheal intubation through two supraglottic devices: Ambu(R) AuraGain laryngeal mask and LMA(R) Fastrach. Anaesth Intensive Care. 2018 Sep;46(5):474-479. doi: 10.1177/0310057X1804600508.'}]}, 'descriptionModule': {'briefSummary': 'The study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Ambu® AuraGain in patients undergoing ambulatory surgery by one anesthetist', 'detailedDescription': 'Supraglottic devices (SGD), in all their different forms, have become an authentic innovation in airway management especially in day surgery. The Ambu® AuraGainTM (Ambu A/S, Ballerup, Denmark) is a new single-use, anatomically curved supraglottic airway with an integrated gastric access port designed to provide functional separation of the respiratory and digestive tracts allowing the exit of gastric contents and the passage of a gastric tube to manage gastric contents.\n\nIts characteristics in the design, composition by a smooth and atraumatic material, the presence of the gastric drainage access, with potential improved patient safety and its characteristic of being disposable, suggests a significant expansion of its use in the coming years.\n\nThe series in the literature reporting performance or safety of use of the Ambu® AuraGainTM come from studies on selected cases and in certain surgical procedures. However, there are limited studies that have evaluated the efficacy of the device in routine clinical practice in patients intervened in ambulatory surgery and performed by a single investigator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients scheduled for outpatient surgery. Patients who require the insertion of a supraglottic device as part of their anesthetic management.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing surgery procedures in ambulatory surgery usually performed with supraglottic devices.\n* ASA physical status I-III patients\n* Age 18-no limit\n\nExclusion Criteria:\n\n* Patients with known difficult airway\n* Patients with increased risk of aspiration\n* Patient refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT04501068', 'briefTitle': 'Evaluation of the Ambu® AuraGain in Ambulatory Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Gregorio Marañon'}, 'officialTitle': 'Analysis of 150 Consecutive Uses of the Ambu® AuraGain Supraglottic Airway by One Anaesthetist in Ambulatory Surgery', 'orgStudyIdInfo': {'id': 'MULTIAURAGAIN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ambu AuraGain', 'description': 'Ambu® AuraGainTM Patients undergoing anesthesia in which airway management includes a Ambu® AuraGainTM supraglottic airway and fulfill the inclusion criteria of the study.', 'interventionNames': ['Device: Ambu® AuraGainTM']}], 'interventions': [{'name': 'Ambu® AuraGainTM', 'type': 'DEVICE', 'description': 'Evaluate the time of insertion, performance, security and insertion success rate of the Ambu® AuraGainTM in patients undergoing ambulatory surgery and general anaesthesia', 'armGroupLabels': ['Ambu AuraGain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Gregorio Maranon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Javier Hortal, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Servicio de Anestesiología, Hospital General Universitario Gregorio Marañón'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario Gregorio Marañon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Matilde Zaballos', 'investigatorAffiliation': 'Hospital General Universitario Gregorio Marañon'}}}}