Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT03110393
Status:
COMPLETED
Last Update Posted:
2018-01-08
First Post:
2017-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ambu®AuraGain™ Versus I-gel® in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-05', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of successful intubation', 'timeFrame': 'intraoperative', 'description': 'Measurement of a fiberoptic intubation with the laryngeal mask. Start: Insertion of the fiberoptic into the larynxmask until the intubation has been done and after the fiberoptic has been removed.'}], 'secondaryOutcomes': [{'measure': 'Number of Insertions (of the laryngeal mask)', 'timeFrame': 'intraoperative', 'description': 'Number of insertion attempts will be registered'}, {'measure': 'Time of insertion', 'timeFrame': 'intraoperative', 'description': 'The time of Insertion of the laryngeal mask will be recorded.'}, {'measure': 'Number of insertion attempts', 'timeFrame': 'intraoperative', 'description': 'Number of insertions with the stomach tube will be registered'}, {'measure': 'Gastric volume', 'timeFrame': 'intraoperative', 'description': 'Measurement of the gastric volume'}, {'measure': 'Positioning of the gastric probe', 'timeFrame': 'intraoperative', 'description': 'Determination of the position of the gastric probe after successful insertion by stethoscope.'}, {'measure': 'Successful Ventilation', 'timeFrame': 'intraoperative', 'description': 'Detection of a successful Ventilation. There are two options: a tidal volume \\> 6mL/kg lean body mass or endtidal pCO2 \\< 6.7kPa'}, {'measure': 'Oropharyngeal leak pressure of the Ambu®AuraGain ™', 'timeFrame': 'intraoperative', 'description': 'The oropharyngeal leak pressure of the AuraGain™ is measured with a measured cuff volume of 60cmH2O'}, {'measure': 'Oropharyngeal leak pressure of the Intersurgical i-gel®', 'timeFrame': 'intraoperative', 'description': 'The oropharyngeal leak pressure of the Intersurgical i-gel® is measured.'}, {'measure': 'Measurement of blood pressure', 'timeFrame': 'intraoperative', 'description': 'Measurement of blood pressure during 5min (1 measurement / minute).'}, {'measure': 'Measurement of oxygen saturation', 'timeFrame': 'intraoperative', 'description': 'Measurement oxygen saturation during 5min (1 measurement / minute).'}, {'measure': 'Measurement of heart rate', 'timeFrame': 'intraoperative', 'description': 'Measurement of heart rate during 5min (1 measurement / minute).'}, {'measure': 'Maximum ventilation pressure', 'timeFrame': 'intraoperative', 'description': 'The maximum ventilation pressure is measured, which must be applied in order to adequately ventilate the patients. This is measured over 5 minutes'}, {'measure': 'Measurement CO2 (kPa):', 'timeFrame': 'intraoperative', 'description': 'The exhaled CO2 is determined continuously.'}, {'measure': 'Number of intubation attempts', 'timeFrame': 'intraoperative', 'description': 'The number of intubation attempts until successful intubation is recorded.'}, {'measure': 'Reasons for the unsuccessful intubation', 'timeFrame': 'intraoperative', 'description': 'The reasons are listed in tabular form.'}, {'measure': 'Number of esophageal intubations', 'timeFrame': 'intraoperative', 'description': 'The number of esophageal intubations is measured.'}, {'measure': 'Resistance (for an EET):', 'timeFrame': 'intraoperative', 'description': 'The resistance is measured with a score of 1- 4. 1: simple passage, no resistance, 2: little resistance for the passage, 3: significant resistance for the passage, 4: passage not possible'}, {'measure': 'Location of the mask (Brimacombe)', 'timeFrame': 'intraoperative', 'description': 'The position of the mask is determined by pushing the fiber optic to a maximum of 1cm over the LMA and then using the Brimacombe score.'}, {'measure': 'Swallowing (no / little / medium / strong)', 'timeFrame': '5hour postoperative', 'description': 'The swallowing difficulties are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).'}, {'measure': 'Throat pain (no / little / medium / strong)', 'timeFrame': '5hour postoperative', 'description': 'The throat pain is questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).'}, {'measure': 'Hoarseness (no / little / medium / strong)', 'timeFrame': '5hour postoperative', 'description': 'The swallowing difficulties, the throat pain and the hoarseness are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).'}, {'measure': 'Blood on laryngeal mask after intubation', 'timeFrame': 'intraoperative', 'description': 'Determination of the visible blood on the laryngeal mask after removal (no, little, much).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obese', 'Laryngeal Mask Airway', 'Anaesthesia'], 'conditions': ['Obese']}, 'referencesModule': {'references': [{'pmid': '30088266', 'type': 'DERIVED', 'citation': 'Moser B, Keller C, Audige L, Dave MH, Bruppacher HR. Fiberoptic intubation of severely obese patients through supraglottic airway: A prospective, randomized trial of the Ambu(R) AuraGain laryngeal mask vs the i-gel airway. Acta Anaesthesiol Scand. 2019 Feb;63(2):187-194. doi: 10.1111/aas.13242. Epub 2018 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is the randomized comparison of two laryngeal mask (Intersurgical i-gel® and Ambu®AuraGain™) in obese patients', 'detailedDescription': 'Since the incidence of a difficult intubation lies between 4.5% -7.5%, the search for alternative airway devices has been forced in the past.\n\nAs an option, the laryngeal mask is suitable, which has been used as a universal airway with a high degree of safety in routine anesthesia.\n\nThere are numbers of different laryngeal masks available which have the characteristic to insert an endotracheal tube through the ventilation lumen.\n\nThe indications for these laryngeal masks can be extended due to continuous improvements in the laryngeal masks, these laryngeal masks can also be used in obese patients. Obese patients generally have a 4-fold increased risk of a difficult airway, and a BMI over 35 is a predictor of a difficult tracheal intubation.\n\nThere are no studies comparing the Intersurgical i-gel® Laryngeal Mask and the Ambu®AuraGain ™ Laryngeal Mask in obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-3\n* Shoulder-/Elbow-/Hip-/Knee- or Foot - Surgery\n* Signed informed consent\n* BMI \\> 35kg/m2\n\nExclusion Criteria:\n\n* Non-sober patients (last meal \\<6 h)\n* Symptomatic reflux disease\n* Hiatus hernia\n* Significant cardiovascular risk factors\n* Severe COPD\n* Gastric band or gastric bypass\n* Disease which allows an accurate examination of the physicians (e.g. neuromuscular, mental, metabolic disease)\n* Drug or drug abuse in the recent past\n* Legal immaturity (incompetence)\n* Acute disease, which calls into question the narcotic potential\n* Patients with whom the use of a laryngeal mask is contraindicated or otherwise not possible'}, 'identificationModule': {'nctId': 'NCT03110393', 'briefTitle': 'Ambu®AuraGain™ Versus I-gel® in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Schulthess Klinik'}, 'officialTitle': 'Prospective Randomized Comparison Between a Fiber Optic Intubation Via the Ambu® AuraGain ™ or the i-Gel® Laryngeal Mask Until a Complete Airway Protection in Obese Patients', 'orgStudyIdInfo': {'id': 'Schulthess_Anä_10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ambu® AuraGain™', 'description': 'Intervention with Ambu® AuraGain™Laryngeal Mask', 'interventionNames': ['Device: Ambu AuraGain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intersurgical i-gel®', 'description': 'Intervention with Intersurgical i-gel® Laryngeal Mask', 'interventionNames': ['Device: Intersurgical i-gel']}], 'interventions': [{'name': 'Ambu AuraGain', 'type': 'DEVICE', 'description': 'Insert and intubation of an Ambu® AuraGain™ laryngeal mask', 'armGroupLabels': ['Ambu® AuraGain™']}, {'name': 'Intersurgical i-gel', 'type': 'DEVICE', 'description': 'Insert and intubation of an Intersurgical i-gel®', 'armGroupLabels': ['Intersurgical i-gel®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Schulthess Klinik', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Berthold Berthold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schulthess Klinik'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schulthess Klinik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Berthold Moser', 'investigatorAffiliation': 'Schulthess Klinik'}}}}