Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-01 @ 12:46 AM
Study NCT ID:
NCT03169556
Status:
COMPLETED
Last Update Posted:
2017-10-30
First Post:
2017-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Conventional Lightwand Intubation Versus Video-laryngoscope Guided Lightwand Intubation in Simulated Cervical Spine-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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-26', 'studyFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2017-05-25', 'lastUpdatePostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The success rate of intubation', 'timeFrame': 'Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.', 'description': 'Confirm the success intubation through end-tidal carbon dioxide on a capnography'}, {'measure': 'The duration of intubation', 'timeFrame': 'Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.', 'description': 'Define as the duration between insertion of lightwand or video-laryngoscope to oral cavity and removal all intubating devices from oral cavity.'}], 'secondaryOutcomes': [{'measure': 'number of intubation trial and scooping movements', 'timeFrame': 'during intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time', 'description': 'The number of intubation tiral and scooping movements during intubation'}, {'measure': 'Blood pressure change', 'timeFrame': 'from start of intubation to 5minute after intubation', 'description': 'The difference between maximum mean blood pressure and minimum blood pressure'}, {'measure': 'Injuries of oral cavity', 'timeFrame': 'at immediate after intubation and extubation', 'description': 'Check any blood in lips, teeth, endotracheal cuff, and oral cavity'}, {'measure': 'Postoperative hoarseness', 'timeFrame': 'at 1hr after PACU arrival and 24hr after operation', 'description': 'Check "Yes or No" through questioning the patient'}, {'measure': 'Postoperative sore throat', 'timeFrame': 'at 1hr after PACU arrival and 24hr after operation', 'description': 'Check using visual analog scale (0-100 points)'}, {'measure': 'Heart rate change', 'timeFrame': 'from start of intubation to 5minute after intubation', 'description': 'The difference between maximum heart rate and minimum minimum heart rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intubation', 'light wand', 'video laryngoscopy', 'cervical spine immobilization'], 'conditions': ['General Anesthesia']}, 'descriptionModule': {'briefSummary': 'Among advanced intubation equipment for difficult intubation, a lighted stylet (lightwand) is a widely used equipment in cervical immobilized patients. However, a lightwand, which is used blind, is difficult to make midline positioning and can increase airway complications and hemodynamic changes. In contrast, videolaryngoscope can view vocal cord indirectly through camera, however, it requires cervical movement. Therefore, investigator hypothesized that the combined use of video-laryngoscope and lightwand for intubation can improve the efficacy of intubation compared to the use of lightwand alone in cervical immobilized patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged between 20- 80 yrs\n2. Patients scheduled surgery under the general anesthesia\n\nExclusion Criteria:\n\n1. Patient who has history of gastro-esophageal reflux disease, previous airway surgery, anatomical abnormality in the upper airway, or coagulopathy\n2. Patients with body mass index \\>35kg/m2, hemodynamic instability or loosening teeth\n3. Patient who disagrees to participate this study or lacks decision-making ability, illiteracy, or foreigner\n4. American Society of Anesthesiologists physical status ≥ 3'}, 'identificationModule': {'nctId': 'NCT03169556', 'briefTitle': 'Comparison of Conventional Lightwand Intubation Versus Video-laryngoscope Guided Lightwand Intubation in Simulated Cervical Spine-immobilized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Comparison of Conventional Lightwand Intubation Versus Video-laryngoscope Guided Lightwand Intubation in Simulated Cervical Spine-immobilized Patients', 'orgStudyIdInfo': {'id': '1-2016-0069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'video-laryngoscope guided lightwand', 'interventionNames': ['Device: Video-laryngoscope guided lightwand']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lightwand', 'interventionNames': ['Device: lightwand alone']}], 'interventions': [{'name': 'Video-laryngoscope guided lightwand', 'type': 'DEVICE', 'otherNames': ['Video laryngoscope (VL310, Zhejiang UE Medical, Zhejiang, China)'], 'description': 'After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. For intubation, video-laryngoscope is inserted into the oral cavity ntil the epiglottis tip was visible without lifting the epiglottic vallecula. Then, the endotracheal tube with lightwand is inserted toward the midline under the epiglottis and the intubation is performed looking the transilluminated light of lightwand.', 'armGroupLabels': ['video-laryngoscope guided lightwand']}, {'name': 'lightwand alone', 'type': 'DEVICE', 'otherNames': ['LightWand (3960, GE Healthcare, Englewood, USA)'], 'description': 'After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. Then, the endotracheal tube with lightwand is inserted and the intubation is performed with conventional method (blind technique by confirming transillumination).', 'armGroupLabels': ['lightwand']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}