Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-05 @ 9:22 AM
Study NCT ID:
NCT04346459
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2020-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-09-02', 'unreleaseDate': '2025-09-10'}], 'estimatedResultsFirstSubmitDate': '2025-09-02'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-30', 'studyFirstSubmitDate': '2020-04-10', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of intubation at first attempt', 'timeFrame': 'Up to study completion, an average of 2 years', 'description': 'Recording of successful tracheal intubation at first attempt (yes/no) and evaluation of the success rate at first attempt'}], 'secondaryOutcomes': [{'measure': 'Time required for tracheal intubation', 'timeFrame': 'Up to study completion, an average of 2 years', 'description': 'Time required from the beginning of the insertion of the supraglottic airway device/ laryngeal mask until the endotracheal tube is successfully placed confirmed by continuous waveform capnography (3 cycles)'}, {'measure': 'Time required for successful supraglottic airway device/ laryngeal mask placement', 'timeFrame': 'Up to study completion, an average of 2 years', 'description': 'Time required from the beginning of the insertion of the supraglottic airway device/ laryngeal mask until adequate ventilation is confirmed by continuous waveform capnography (3 cycles)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tracheal intubation', 'supraglottic airway device'], 'conditions': ['Tracheal Intubation']}, 'descriptionModule': {'briefSummary': 'This study compares three different supraglottic airway devices used as a conduit for tracheal intubation in order το determine which one achieves the highest success rate of first attempt intubation', 'detailedDescription': "Prospective, randomized, comparative, clinical, controlled study, that is approved by the Ethics Commitee of the University of Patras (10.12.2019) and takes part in the University Hospital of Patras. Depending on the supraglottic airway device (SGA)/ laryngeal mask airway (LMA) used to achieve intubation (Fastrach, I-gel, Protector), partcipants will be randomly allocated into three groups; Group A, B and C (Fastrach, I-gel, Protector respectively).\n\nIn the preoperative setting, a complete preanesthetic evaluation will be performed, including a detailed airway assessment (prediction of difficulty in face mask ventilation, insertion of SGA/LMA and intubation).\n\nAll patients are scheduled to undergo an elective surgery under general anesthesia. Before induction, all patients will be preoxygenated with FiO2 100% for at least 5 minutes. After induction, using rocuronium 0.6mg/kg to facilitate neuromuscular blockade, face mask ventilation follows.\n\n1. Group A- Fastrach: The intubating laryngeal mask airway (Fastrach) will be placed to the patients of this group. After the mask is correctly placed and patients are adequately ventilated, they will be intubated through the mask using its own endotracheal tube according to the blind technique insertion.\n2. Group B- I-gel: The supraglottic airway device (I-gel) will be placed to the patients of this group. After the mask is correctly placed and patients are adequately ventilated, they will be intubated through the mask using a fiberoptic bronchoscope to guide endotracheal tube's placement.\n3. Group C- Protector: The supraglottic airway device (Protector) will be placed to the patients of this group. After the mask is correctly placed and patients are adequately ventilated, they will be intubated through the mask using a fiberoptic bronchoscope to guide endotracheal tube's placement.\n\nIn all groups (A, B, C) up to 3 attempts of SGA/LMA placement and up to 3 attempts of intubation are allowed to be made.\n\nIn case of an emerging unpredicted difficult airway and a concurrent unsuccessful SGA/LMA placement, then the algorithm of the difficult airway will be immediately followed. Video-assisted laryngoscopy will be the first option rescue alternative.\n\nThe time of the whole procedure from the beginning of SGA's/LMA's placement effort until the successful intubation will be recorded, along with the evaluation of the success rate of first intubation attempt."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (age ≥ 18 yrs) scheduled for an elective surgery under general anesthesia\n* Written informed consent to participate in the trial\n\nExclusion Criteria:\n\n* Age \\< 18 yrs\n* Non- elective (urgent/ emergency) procedures or multi-trauma patients\n* Obstetric population\n* Surgery performed under regional anesthesia\n* Contraindication to LMA insertion\n* Predicted difficulty in LMA insertion (at least one out of four "RODS" criteria)\n* Contraindication to the use of neuromuscular blockade or situations that require spontaneous breathing\n* Indication for awake intubation or surgical airway\n* Patients\' involvement in another clinical trial'}, 'identificationModule': {'nctId': 'NCT04346459', 'briefTitle': 'Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Patras'}, 'officialTitle': 'Evaluation of Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices: A Comparative Randomised Study', 'orgStudyIdInfo': {'id': '11/11/2019anesthesia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A- Fastrach (control group)', 'description': 'Group of 40 patients scheduled for elective surgery under general anesthesia are planned to be intubated using intubating laryngeal mask airway "Fastrach" following blind intubating method through "Fastrach"', 'interventionNames': ['Procedure: Tracheal intubation through "Fastrach" - Group A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B- I-gel', 'description': 'Group of 40 patients scheduled for elective surgery under general anesthesia are planned to be intubated using "I-gel" supraglottic airway device as a conduit for tracheal intubation guided by a fiberoptic bronchoscope.', 'interventionNames': ['Procedure: Tracheal intubation through "I-gel" - Group B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C- Protector', 'description': 'Group of 40 patients scheduled for elective surgery under general anesthesia are planned to be intubated using the "Protector" laryngeal mask airway as a conduit for tracheal intubation guided by a fiberoptic bronchoscope.', 'interventionNames': ['Procedure: Tracheal intubation through "Protector" - Group C']}], 'interventions': [{'name': 'Tracheal intubation through "Fastrach" - Group A', 'type': 'PROCEDURE', 'description': 'Insertion of the intubating laryngeal mask "Fastrach" and blind tracheal intubation through the device', 'armGroupLabels': ['Group A- Fastrach (control group)']}, {'name': 'Tracheal intubation through "I-gel" - Group B', 'type': 'PROCEDURE', 'description': 'Insertion of the supraglottic airway device "i-gel" and tracheal intubation through the device guided by a fiberoptic bronchoscope', 'armGroupLabels': ['Group B- I-gel']}, {'name': 'Tracheal intubation through "Protector" - Group C', 'type': 'PROCEDURE', 'description': 'Insertion of the laryngeal mask "Protector" and tracheal intubation through the device guided by a fiberoptic bronchoscope', 'armGroupLabels': ['Group C- Protector']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26500', 'city': 'Pátrai', 'state': 'Achaia', 'country': 'Greece', 'facility': 'University Hospital of Patras', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}], 'overallOfficials': [{'name': 'Gregorios Voyagis, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Patras, Department of Anesthesiology and Critical Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Patras', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maria Spyraki', 'investigatorAffiliation': 'University Hospital of Patras'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-02', 'type': 'RELEASE'}, {'date': '2025-09-10', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'Maria Spyraki, Consultant Anaesthesiologist, MD, MSc, PhDc, University Hospital of Patras'}}}}