Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 4:03 PM
Study NCT ID:
NCT06119360
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Different Lightwand Intubation Techniques in Cervical Immobilized Patients
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': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-02', 'studyFirstSubmitDate': '2023-10-30', 'studyFirstSubmitQcDate': '2023-11-02', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immediate intubation related outcomes', 'timeFrame': 'Immediately after general anesthesia (at the post anesthesia care unit)', 'description': 'Outcomes after tracheal intubation'}, {'measure': '24 hours intubation related outcomes', 'timeFrame': '24 hours after general anesthesia (at the general ward)', 'description': 'Outcomes after tracheal intubation'}], 'primaryOutcomes': [{'measure': 'Initial success rate', 'timeFrame': 'during intubation', 'description': 'Intubation success rate at the first attempt'}], 'secondaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': 'during intubation', 'description': 'Total time to the successful intubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation; Difficult or Failed']}, 'descriptionModule': {'briefSummary': 'This study compares two different approaches of lightwand intubation techniques in cervical immobilized patients.', 'detailedDescription': 'This study compares two approaches in lightwand intubation techniques in cervical immobilized patients. One is a conventional approach that involves scooping movement with mandible protraction. The other is a face-to-face approach that inserts lightwand with a front-facing position. This study is conducted as a randomized, prospective, single-blinded design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults with American Society of Anesthesiologists physical status 1-3\n* patients who received scheduled spine surgery under general anesthesia\n\nExclusion Criteria:\n\n* patients with body mass index \\<18.5 kg/m2 or \\>35.0 kg/m2,\n* patients who previously had head and neck surgery,\n* patients who are at high risk of aspiration,\n* patients with pathologic conditions such as tumors, polyps, or inflammation in the airway,\n* patients who cannot sit due to severe spine deformity,\n* patients who have compromised cardiopulmonary function patients with clinically significant neurovascular disease'}, 'identificationModule': {'nctId': 'NCT06119360', 'briefTitle': 'Comparison of Two Different Lightwand Intubation Techniques in Cervical Immobilized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kyung Hee University Hospital at Gangdong'}, 'officialTitle': 'Comparison of the Intubation Success Rate Between Two Techniques Using Lightwand in Patients Undergoing Spine Surgery: Conventional vs. Face-to-face Technique', 'orgStudyIdInfo': {'id': 'KHNMC 2018-10-011-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group Conventional', 'description': 'Conventional approach using group in lightwand intubation', 'interventionNames': ['Procedure: Conventional approach']}, {'type': 'OTHER', 'label': 'Group Face-to-Face', 'description': 'Face-to-face approach using group in lightwand intubation', 'interventionNames': ['Procedure: Face-to-face approach']}], 'interventions': [{'name': 'Face-to-face approach', 'type': 'PROCEDURE', 'description': "A front-facing approach and insert the lightwand following the patient's tongue base curvature without scooping movement", 'armGroupLabels': ['Group Face-to-Face']}, {'name': 'Conventional approach', 'type': 'PROCEDURE', 'description': "Patients were positioned supine and the intubator stood above the patient's head. Opening the mouth and slightly pulling the mandible with one hand, the intubator inserted the lightwand-tracheal tube assembly at midline into the patient's mouth under the ambient light being turned off. To identify the location of the lighted tip, the intubator could move the lightwand back and forth gently, Once the red light of the tip was located at the midline of the patient's neck, the pre-launched tube was inserted smoothly into the patient's airway unless there was no resistance", 'armGroupLabels': ['Group Conventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05278', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Gangdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyungseok Suh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee University Hospital at Gangdong-gu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyung Hee University Hospital at Gangdong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hyungseok Seo', 'investigatorAffiliation': 'Kyung Hee University Hospital at Gangdong'}}}}