Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:32 AM
Study NCT ID:
NCT07467005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Double-Lumen Tube for Secondary Pulmonary Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of intraoperative hypoxemia', 'timeFrame': 'During the entire intraoperative period'}], 'primaryOutcomes': [{'measure': 'Success rate of first-attempt bronchial intubation', 'timeFrame': 'During the first intubation attempt'}], 'secondaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': 'Measured from insertion of the video laryngoscope into the mouth until confirmation of correct tube position'}, {'measure': 'Requirement for and number of fiberoptic bronchoscopy uses', 'timeFrame': 'During the entire intraoperative period'}, {'measure': 'Frequency of intraoperative tube repositioning', 'timeFrame': 'During the entire intraoperative period'}, {'measure': "Surgeon's rating of lung collapse quality", 'timeFrame': 'During the entire intraoperative period'}, {'measure': 'Incidence of difficult intubation', 'timeFrame': 'At the time of intubation'}, {'measure': 'Intubation-related adverse events', 'timeFrame': 'From the start of intubation until 24 hours postoperatively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['First-attempt Intubation Success Rate', 'One-lung Ventilation', 'video double-lumen tube', 'secondary pulmonary resection'], 'conditions': ['Lung Cancer', 'Pulmonary Nodule']}, 'descriptionModule': {'briefSummary': 'During thoracic surgery, double-lumen endotracheal intubation with one-lung ventilation is routinely performed to optimize surgical exposure, facilitate operative manipulation, and prevent iatrogenic lung injury. In patients undergoing repeat pulmonary surgery, prior lung resection may lead to pleural adhesions and tracheobronchial distortion, which substantially increase the difficulty of bronchial intubation. Even with experienced operators, the malposition rate of conventional double-lumen tubes remains high. The video double-lumen tube enables continuous visualization of the trachea and carina during insertion, positioning, and one-lung ventilation, allowing real-time airway monitoring. However, no clinical studies have specifically investigated airway management in patients undergoing redo pulmonary surgery. This study aimed to evaluate the efficacy and safety of the video double-lumen tube during anesthesia in patients undergoing secondary pulmonary resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* History of previous pulmonary resection.\n* Scheduled for elective pulmonary surgery.\n* Planned to receive a left-sided double-lumen tube.\n* ASA physical status I-III.\n* Patients have signed the informed consent form.\n\nExclusion Criteria:\n\n* Preoperatively predicted difficult airway (Mallampati ≥ III, Cormack-Lehane ≥ III).\n* Acute respiratory distress syndrome (ARDS) or respiratory failure within the past 3 months.\n* Uncontrolled asthma.\n* Confirmed pregnancy or current breastfeeding.\n* Multiple traumatic injuries.\n* Current participation in another clinical trial.\n* Other conditions deemed unsuitable by the investigator.'}, 'identificationModule': {'nctId': 'NCT07467005', 'briefTitle': 'Video Double-Lumen Tube for Secondary Pulmonary Resection', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Video Double-Lumen Tube for Secondary Pulmonary Resection: A Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ZJU2025B0593'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video Double-Lumen Tube Group', 'interventionNames': ['Device: Video Double-Lumen Tube Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Double-Lumen Tube', 'interventionNames': ['Device: Conventional Double-Lumen Tube Group']}], 'interventions': [{'name': 'Video Double-Lumen Tube Group', 'type': 'DEVICE', 'description': 'Use the video double-lumen tube to perform left bronchial intubation under real-time visualization and continuously monitor its position.', 'armGroupLabels': ['Video Double-Lumen Tube Group']}, {'name': 'Conventional Double-Lumen Tube Group', 'type': 'DEVICE', 'description': 'Insert a conventional left-sided double-lumen tube using standard intubation techniques.', 'armGroupLabels': ['Conventional Double-Lumen Tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Diansan Su', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+86 18616514088'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Pingbo Xu', 'role': 'CONTACT', 'email': 'xupingboshanghai@163.com', 'phone': '+86 15700074964'}], 'facility': 'Zhejiang Cancer hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '322000', 'city': 'Yiwu', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Jianhong Xu', 'role': 'CONTACT', 'email': '1197058@zju.edu.cn', 'phone': '+86 17280781160'}], 'facility': 'The Fourth Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 29.31506, 'lon': 120.07676}}], 'centralContacts': [{'name': 'Diansan Su', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+86 18616514088'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician,Researcher', 'investigatorFullName': 'Diansan Su', 'investigatorAffiliation': 'Zhejiang University'}}}}