Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT02048657
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2013-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-27', 'studyFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2014-01-27', 'lastUpdatePostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with successful airway establishment', 'timeFrame': 'half an hour', 'description': 'successful airway establishment is defined as adequate ventilation with ProSeal LMA and its alignment with viewing of proper glottic and esophageal positions.'}], 'secondaryOutcomes': [{'measure': 'postoperative sore throat', 'timeFrame': '2 days', 'description': 'sore throat recorded in recovery room and in the coming morning'}, {'measure': 'hoarseness', 'timeFrame': '2 days', 'description': 'severity of hoarseness was recorded in recovery room and in the coming morning'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LMA, Foley Airway Stylet Tool (FAST), introducer-tool (I-Tool)'], 'conditions': ['Anesthesia Insertion Complication', 'Airway Morbidity']}, 'referencesModule': {'references': [{'pmid': '25435806', 'type': 'DERIVED', 'citation': 'Chen MK, Hsu HT, Lu IC, Shih CK, Shen YC, Tseng KY, Cheng KI. Techniques for the insertion of the ProSeal laryngeal mask airway: comparison of the Foley airway stylet tool with the introducer tool in a prospective, randomized study. BMC Anesthesiol. 2014 Nov 18;14:105. doi: 10.1186/1471-2253-14-105. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed. The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a soft, direct optical Foley airway stylet tool (FAST) and compared with the standard introducer-tool (I-Tool).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients with American Society of Anesthesiologists physical status I-II\n2. aged 20-65 years\n3. requiring LMA Intubation under general anesthesia\n4. unlimited mouth open\n5. unlimited neck motion\n\nExclusion Criteria:\n\n1. mouth open \\< 3 cm\n2. limited neck motion\n3. BMI≧35 kg/m2'}, 'identificationModule': {'nctId': 'NCT02048657', 'briefTitle': 'The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'The Efficiency of ProSeal Laryngeal Mask Airway Insertion: Compared the Techniques of Foley Airway Stylet Tool With Introducer-Tool', 'orgStudyIdInfo': {'id': 'KMHK-IRB-96023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foley group', 'description': 'The Foley Airway Stylet Tool was used to guide ProSeal LMA insertion', 'interventionNames': ['Device: Foley Airway Stylet Tool']}, {'type': 'EXPERIMENTAL', 'label': 'I-Tool group', 'description': 'the ProSeal LMA was inserted with a standard introducer-tool', 'interventionNames': ['Device: introducer-tool']}], 'interventions': [{'name': 'Foley Airway Stylet Tool', 'type': 'DEVICE', 'armGroupLabels': ['Foley group']}, {'name': 'introducer-tool', 'type': 'DEVICE', 'armGroupLabels': ['I-Tool group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'state': 'Kaohsiung', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Kuang I Cheng, MD, PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of anesthesiology, Kaohsiung Medical University, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}