Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-01 @ 12:34 PM
Study NCT ID:
NCT04680169
Status:
COMPLETED
Last Update Posted:
2021-06-21
First Post:
2020-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
I-gel vs AuraGain for Bronchoscopic Intubation Through SGA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-18', 'studyFirstSubmitDate': '2020-12-17', 'studyFirstSubmitQcDate': '2020-12-21', 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reason for failed intubation', 'timeFrame': 'Up to study completion, an average of 4 months', 'description': 'if failed (as described in outcome 4), reason of failure is described'}, {'measure': 'Feeling of resistance during tracheal intubation', 'timeFrame': 'Up to study completion, an average of 4 months', 'description': 'Physician will be asked to report resistance as: none, mild, severe, impossible'}, {'measure': 'Feasibility of SGA placement', 'timeFrame': 'Up to study completion, an average of 4 months', 'description': 'Physician will be asked to report feasibility at a scale 1-10, 1=easy, 10=very difficult'}, {'measure': 'Feasibility of intubation', 'timeFrame': 'Up to study completion, an average of 4 months', 'description': 'Physician will be asked to report feasibility at a scale 1-10, 1=easy, 10=very difficult'}, {'measure': 'Feasibility of total airway management', 'timeFrame': 'Up to study completion, an average of 4 months', 'description': 'Physician will be asked to report feasibility of the whole procedure at a scale 1-10, 1=easy, 10=very difficult'}, {'measure': 'Best Brimacombe score', 'timeFrame': 'Up to study completion, an average of 4 months', 'description': 'Class 1: Unable to see the vocal cords. Class 2: the vocal cords and the anterior aspect of the epiglottis are visualized. Class 3: the vocal cords and the posterior aspect of the epiglottis are observed. Grade 4: only vocal cords were observed.'}], 'primaryOutcomes': [{'measure': 'Total time for airway management', 'timeFrame': 'Up to study completion, an average of 4 months', 'description': 'Total time from reaching the SGA with hands to ended bronchoscopic tracheal intubation confirmed by the end of first curve on capnography'}], 'secondaryOutcomes': [{'measure': 'Time to placement of SGA', 'timeFrame': 'Up to study completion, an average of 4 months', 'description': 'Time measured from reaching SGA with hands to correct placement of SGA confirmed by end of first curve on capnography'}, {'measure': 'Time to trans-device tracheal intubation', 'timeFrame': 'Up to study completion, an average of 4 months', 'description': 'time measured from confirmed placement of SGA until successful tracheal intubation confirmed by end of first curve on capnography'}, {'measure': 'Number of attempts needed for correct placement of SGA', 'timeFrame': 'Up to study completion, an average of 4 months', 'description': 'two attempts at correct placement allowed. Attempt is failed if no curve appears on capnography.'}, {'measure': 'Number of attempts needed for correct intubation', 'timeFrame': 'Up to study completion, an average of 4 months', 'description': 'Attempt of bronchoscopic intubation begins when entering aScope in swivel. Attempt is failed if airway is not visualised, if tracheal tube can not be advanced in trachea, if SpO2 is \\<85% or if total time exceeds 6 minutes. Three attempts of intubation is allowed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intubation', 'Bronchoscopic', 'Supraglottic airway device', 'I-gel', 'AuraGain', 'Flexible', 'Fiberoptic'], 'conditions': ['Airway Management']}, 'descriptionModule': {'briefSummary': 'This trial compares two different second generation supraglottic airway devices (AuraGain and I-gel) used as a conduit for bronchoscopic tracheal intubation during continuous oxygenation in order tο determine time to successful tracheal intubation and ease of use.', 'detailedDescription': 'A prospective randomized controlled trial in the Department of Anesthesiology, Copenhagen University Hospital Nordsjællands Hospital-Hillerød Denmark. The study is approved by the Ethics Committee, capital region of Denmark. The aim of the study is to compare bronchoscopic tracheal intubation during continuous oxygenation through the AuraGain and I-gel supraglottic airway device. One hundred patients will be randomly allocated into two groups, group A (AuraGain) and group B (I-gel). Study outcomes are time to tracheal intubation confirmed by capnography as well as anesthesiologists reports of ease of use. Twenty-five anesthesiologists participates in this study, and are allocated four patient each. In random order, each physician will perform two bronchoscopic tracheal intubations with each SGA.\n\nIn the preoperative setting, a complete anesthetic evaluation will be performed, including a detailed airway assessment determining predictors for difficulties of face mask ventilation, insertion of SGA and tracheal intubation. Participants are scheduled to undergo elective surgery under general anesthesia. Before induction, all patients will be preoxygenated with 100% oxygen. After induction, rocuronium 0.6mg/kg will be used to facilitate neuromuscular blockade. Sufficient face mask ventilation will be performed before intervention.\n\nGroup A: AuraGain:\n\nTime is measured from when the anesthesiologist reaches for the AuraGain LMA until the mask is placed and adequate ventilation is confirmed by capnography. The AuraGain LMA will be used as conduit for bronchoscopic intubation during continuous oxygenation, and time is measured until placement of the tracheal tube verified by capnography.\n\nGroup B: I-gel:\n\nTime is measured from when the anesthesiologist reaches for the I-gel LMA until the mask is placed and adequate ventilation is confirmed by capnography.The I-gel LMA will be used as conduit for bronchoscopic tracheal intubation during continuous oxygenation, and time is measured until placement of the tracheal tube verified by capnography.\n\nIn both groups (A and B) up to two attempts of SGA placement and up to three attempts of tracheal intubation are allowed.\n\nIn case of an emerging unpredicted difficult airway and a concurrent unsuccessful SGA placement, the difficult airway algorithm, DAS, UK will be followed. Video- assisted laryngoscopy will be the first option.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for a non-acute ENT, gynaecological, gastrointestinal or orthopaedic surgical procedure for which general anaesthesia including oral intubation with an endotracheal tube will be provided\n\nExclusion Criteria:\n\n* Age\\<18 years\n* Inter-incisional distance \\<30mm\n* Pregnant and BMI\\>40kg/m2\n* ASA physical status classification system grade \\>3\n* Earlier laryngeal or pharyngeal surgery\n* Increased risk of aspiration (e.g. nasogastric tube inserted, planned Rapid Sequence Induction)\n* Informed consent cannot be obtained\n* Patients with stridor\n* Patients with hypoxemia defines by saturation \\<90 without oxygen at arrival to the operating room\n* Use of oxygen supply at home\n* Need of one of the following special endotracheal tubes for scheduled surgery: neural integrity monitor (NIM) electromyogram (EMG) tracheal tubes, wire tubes\n* Patients scheduled for any awake approach to secure the airway e.g. awake videolaryngoscopy, awake fiberoptic bronchoscope intubation'}, 'identificationModule': {'nctId': 'NCT04680169', 'briefTitle': 'I-gel vs AuraGain for Bronchoscopic Intubation Through SGA', 'organization': {'class': 'OTHER', 'fullName': 'Nordsjaellands Hospital'}, 'officialTitle': 'I-gel Versus AuraGain for Bronchoscopic Intubation Through Supraglottic Airway Device - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Intubation through SGA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: Bronchoscopic intubation using AuraGain LMA as conduit', 'description': 'A group of 50 patients randomly allocated to bronchoscopic intubation using AuraGain', 'interventionNames': ['Device: Bronchoscopic intubation through AuraGain LMA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: Bronchoscopic intubation with I-gel SGA as conduit', 'description': 'A group of 50 patients randomly allocated to bronchoscopic intubation using I-gel', 'interventionNames': ['Device: Bronchoscopic intubation through I-gel SGA']}], 'interventions': [{'name': 'Bronchoscopic intubation through AuraGain LMA', 'type': 'DEVICE', 'description': 'Comparing two different SGAs as conduit for bronchoscopic tracheal intubation', 'armGroupLabels': ['Group A: Bronchoscopic intubation using AuraGain LMA as conduit']}, {'name': 'Bronchoscopic intubation through I-gel SGA', 'type': 'DEVICE', 'description': 'Comparing two different SGAs as conduit for bronchoscopic tracheal intubation', 'armGroupLabels': ['Group B: Bronchoscopic intubation with I-gel SGA as conduit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Nordsjaellands Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'overallOfficials': [{'name': 'Charlotte V Rosenstock, Ph.d', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nordsjaellands Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordsjaellands Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}