Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT03542032
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2018-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of I-Gel Laryngeal Mask Airway Placement Methods in Elective Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2018-05-18', 'studyFirstSubmitQcDate': '2018-05-30', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insertion time', 'timeFrame': '2 minutes', 'description': 'Time for successful i-gel insertion'}, {'measure': 'successful insertion number', 'timeFrame': '2 minutes', 'description': 'successful insertion number'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['i-gel', 'jaw-thrust'], 'conditions': ['Effective I -Gel Mask Airway Placement Technique']}, 'descriptionModule': {'briefSummary': 'To compare the jaw thrust maneuver with the conventional technical methods to place the I-Gel laryngeal mask', 'detailedDescription': "Patients who underwent elective surgery under general anesthesia and who were between the ages of 18 and 75 and who had ASA score I-II-III would be included in the study. Patients' mallampati scores, thyromental distances, mouth openings will be recorded.\n\nPatients will be divided into two groups according to supraglottic airway insertion method.\n\nBoth groups will record the insertion time of i-gel, number of trials, operative time, placement complications.\n\nRecorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed.\n\nPatients' postoperative sore throat will be questioned and recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients between the ages of 18 and 75 years\n2. American Society of Anesthesiologists I, II or III\n\nExclusion Criteria:\n\n1. Those with anatomical disorders related to the upper airway\n2. lung disease\n3. gastric regurgitation\n4. Those who have had lung infection in the last 3 weeks\n5. Supraglottic airway vehicle not settled\n6. Those who are hired for any reason\n7. EtCO2\\> 45\n\nAmerican Society of Anesthesiologists 4 or 5\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03542032', 'briefTitle': 'Comparison of I-Gel Laryngeal Mask Airway Placement Methods in Elective Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Diskapi Training and Research Hospital'}, 'officialTitle': 'Comparison of I -Gel Mask Airway Placement Methods in Elective Surgery: Jaw Thrust Maneuver vs Conventional Technique', 'orgStudyIdInfo': {'id': 'I-Gel'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'jaw-thrust', 'description': "the i-gel was inserted with triple airway maneuver (mouth opening, head extension and jaw thrust) This groups will record the insertion time of i-gel, number of trials, operative time, placement complications.\n\nRecorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed.\n\nPatients' postoperative sore throat will be questioned and recorded.", 'interventionNames': ['Other: i-gel placement maneuvers']}, {'type': 'NO_INTERVENTION', 'label': 'classic group', 'description': "In the classic group, the index finger used as a guide, pushes the back of i-gel towards the hard palate, inserting it into the pharynx till a resistance is felt and the i-gel is then fixed it its place. This groups will record the insertion time of i-gel, number of trials, operative time, placement complications.\n\nRecorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed.\n\nPatients' postoperative sore throat will be questioned and recorded."}], 'interventions': [{'name': 'i-gel placement maneuvers', 'type': 'OTHER', 'description': 'the i-gel was inserted with triple airway maneuver (mouth opening, head extension and jaw thrust) In the classic maneuver , the index finger used as a guide, pushes the back of i-gel towards the hard palate, inserting it into the pharynx till a resistance is felt and the i-gel is then fixed it its place.', 'armGroupLabels': ['jaw-thrust']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Diskapi Yildirim Beyazit Training Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Diskapi Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'ilkay baran akkuş', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}