Ignite Creation Date:
2025-12-24 @ 12:45 PM
Ignite Modification Date:
2025-12-28 @ 2:14 PM
Study NCT ID:
NCT07019961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-13
First Post:
2025-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia: a Randomized Controlled Trial
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-06-05', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of anatomical alignment under fiberoptic bronchoscopy observation', 'timeFrame': 'After insertion of laryngeal mask', 'description': 'Class I: Vocal cords visible. Class II: Vocal cords and posterior epiglottis visible. Class III: Vocal cords and anterior epiglottis visible, \\<50% visual obstruction of epiglottis to vocal cords.\n\nClass IV: Vocal cords and anterior epiglottis visible, \\>50% visual obstruction of epiglottis to vocal cords.\n\nClass V: Vocal cords not visible. We define Class I and II field of view as accurate alignment; Class III and IV vision are defined as poor alignment; Class V vision is defined as alignment failure.'}], 'secondaryOutcomes': [{'measure': 'Number of laryngeal mask insertions', 'timeFrame': 'After anesthesia induction'}, {'measure': 'Placement time of laryngeal mask', 'timeFrame': 'After anesthesia induction'}, {'measure': 'Difficulty level of laryngeal mask insertion', 'timeFrame': 'After insertion of laryngeal mask'}, {'measure': 'Time of insertion of gastric tube through laryngeal mask airway', 'timeFrame': 'After insertion of laryngeal mask'}, {'measure': 'Number of gastric tube insertions', 'timeFrame': 'After insertion of laryngeal mask'}, {'measure': 'Difficulty level of gastric tube insertion', 'timeFrame': 'After insertion of laryngeal mask'}, {'measure': 'Oral and pharyngeal leakage pressure', 'timeFrame': '10 minutes after stable ventilation and 1 hour after ventilation'}, {'measure': 'Accuracy of anatomical alignment under fiberoptic bronchoscopy observation', 'timeFrame': '1 hour after ventilation and at the end of surgery'}, {'measure': 'Success rate of initial ventilation placement', 'timeFrame': 'During the anesthesia process'}, {'measure': 'Success rate of intraoperative ventilation', 'timeFrame': 'During the anesthesia process'}, {'measure': 'Number of laryngeal mask adjustments during surgery', 'timeFrame': 'During the anesthesia process'}, {'measure': 'Intraoperative injury situation', 'timeFrame': 'During the surgical process'}, {'measure': 'Postoperative respiratory complications', 'timeFrame': 'Immediately after anesthesia awakening, 1 hour later, 24 hours later'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GMA-TULIP laryngeal mask', 'i-gel laryngeal mask', 'anatomical alignment of laryngeal mask', 'oropharyngeal leak pressure'], 'conditions': ['Trauma Surgery', 'General Anesthesia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if GMA-TULIP laryngeal mask willfit well in the right place in participants undergoing trauma surgery in a supine position under general anaesthesia.\n\nIt will also learn about the convenience, effectiveness and safety of the GMA-TULIP laryngeal mask.\n\nThe main questions it aims to answer are:\n\nDoes the GMA-TULIP laryngeal mask exhibit better anatomical alignment? Does the GMA-TULIP laryngeal mask perform effectively in trauma surgery patients in a supine position under general anaesthesia? Researchers will compare with the i-gel laryngeal mask (a device already popular among anaesthetists) to see if the GMA-TULIP laryngeal mask works to have a good performance in general anaesthesia.\n\nParticipants will describe feelings immediately after anesthesia， 1 hour later and 24 hours later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n18 years old ≤ age ≤ 70 years old. Patients undergoing trauma surgery in a supine position under general anesthesia.\n\n18 kg/m2 ≤ BMI ≤ 35 kg/m2. American Society of Anesthesiologists (ASA) grades I-III. Can understand the research process and the use of pain scales. Clear understanding and voluntary participation in the study, signing of informed consent form.\n\nExclusion Criteria:\n\nPatients with known or predicted difficult airways. High risk of reflux or aspiration (e.g., gastroesophageal reflux disease patients).\n\nIndividuals with active upper respiratory tract infections. Cervical related diseases or surgical history. Preoperative sore throat or previous sore throat or hoarseness. Patients with oral and maxillofacial trauma or fractures. Other reasons why researchers believe it is not appropriate to participate in the experiment.'}, 'identificationModule': {'nctId': 'NCT07019961', 'briefTitle': 'Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KYLL-202502-002-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G group', 'description': 'Participants who will use the GMA-TULIP laryngeal mask', 'interventionNames': ['Device: the GMA-TULIP laryngeal mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'I Group', 'description': 'Participants who will use the i-gel laryngeal mask', 'interventionNames': ['Device: the i-gel laryngeal mask']}], 'interventions': [{'name': 'the GMA-TULIP laryngeal mask', 'type': 'DEVICE', 'description': 'insert GMA-TULIP laryngeal masks after anesthesia induction', 'armGroupLabels': ['G group']}, {'name': 'the i-gel laryngeal mask', 'type': 'DEVICE', 'description': 'insert i-gel laryngeal masks after anesthesia induction', 'armGroupLabels': ['I Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Shaozhong Yang, Doctor', 'role': 'CONTACT', 'email': 'yszyang@163.com', 'phone': '+86 18560083790'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Shaozhong Yang, Doctor', 'role': 'CONTACT', 'email': 'yszyang@163.com', 'phone': '+86 18560083790'}], 'overallOfficials': [{'name': 'Shaozhong Yang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'After the research is completed, share research data, research plans, statistical analysis plans, informed consent forms, and other data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}