Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-02-24 @ 5:46 AM
Study NCT ID:
NCT01517204
Status:
COMPLETED
Last Update Posted:
2012-09-18
First Post:
2011-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube
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': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-16', 'studyFirstSubmitDate': '2011-11-15', 'studyFirstSubmitQcDate': '2012-01-20', 'lastUpdatePostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main outcome measure is the successful rate of the first intubation', 'timeFrame': '12 month'}], 'secondaryOutcomes': [{'measure': 'The outcome measure is the time needed to insert the DLT', 'timeFrame': '12 months'}, {'measure': 'The outcome measure is mean blood pressure (MAP) during intubation period', 'timeFrame': '12 months', 'description': 'MAP was measured before intubation, and after intubation 1, 3,and 5 min.'}, {'measure': 'The outcome measure is the heart rate (HR) during intubation period', 'timeFrame': '12 months', 'description': 'HR was measured and recorded before intubation, and after intubation 1, 3,and 5 min.'}, {'measure': 'The outcome measure is the incidence of hypoxemia.', 'timeFrame': '12 months', 'description': 'Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the period of intubation.'}, {'measure': 'The outcome measure is the incidence of sore throat.', 'timeFrame': '12 months', 'description': 'Sore throat was observed and evaluated after extubation and patient regained consciousness.'}, {'measure': 'The outcome measure is the incidence of hoarseness.', 'timeFrame': '12 months', 'description': 'Hoarseness was observed and evaluated after extubation and patient regained consciousness.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Trachway(R) intubating stylet', 'Left sided double lumen endobronchial tube', 'Efficacy', 'Intubation complication'], 'conditions': ['Anesthesia Intubation Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of Trachway(R) compared with direct laryngoscope in tracheal intubation of double-lumen endobronchial tube.', 'detailedDescription': 'Intubation with the double-lumen endobronchial tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management.\n\nThe larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of Trachway(R)compared with direct laryngoscope in DLT intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. patients with American Society of Anesthesiologists physical status I-III\n2. More than 18 years of age\n3. Requiring DLT for thoracic surgery\n\nExclusion Criteria:\n\n1. risk of regurgitation and pulmonary aspiration\n2. history of gastroesophageal reflux, pregnancy\n3. scheduled tracheostomy and postoperative prolonged ventilation in ICU\n4. patients with limited neck extension (\\< 35°)\n5. a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm\n6. a sternomental distance of less than 12.5 cm with the head fully extended\n7. mouth can not open"}, 'identificationModule': {'nctId': 'NCT01517204', 'briefTitle': 'The Efficacy of Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'The Comparison of Direct Laryngoscope and Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube', 'orgStudyIdInfo': {'id': 'KMUH-IRB-990305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Direct laryngoscope', 'description': 'Direct laryngoscope was used to facilitate the intubation of left-sided double lumen endobronchial tube.', 'interventionNames': ['Device: Direct laryngoscope (Macintoish laryngoscope)']}, {'type': 'EXPERIMENTAL', 'label': 'Trachway(R) intubating stylet', 'description': 'Trachway(R) intubating stylet was used to facilitate left-sided double lumen endobronchial tube intubation.', 'interventionNames': ['Device: Trachway(R) intubating stylet']}], 'interventions': [{'name': 'Direct laryngoscope (Macintoish laryngoscope)', 'type': 'DEVICE', 'otherNames': ['Macintoish laryngoscope'], 'description': 'Direct laryngoscope was used to facilitate the intubation of left-sided DLT.', 'armGroupLabels': ['Direct laryngoscope']}, {'name': 'Trachway(R) intubating stylet', 'type': 'DEVICE', 'otherNames': ['The Clarus Video System'], 'description': 'Trachway(R) intubating stylet was used to facilitate the intubation of left-sided DLT.', 'armGroupLabels': ['Trachway(R) intubating stylet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'state': 'Kaohsiung', 'country': 'Taiwan', 'facility': 'department of anesthesia, Kaohsiung medical university memorial hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Hung-Te Hsu, VS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of anesthesia, Kaoshiung medical university hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}