Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-03-02 @ 4:05 PM
Study NCT ID:
NCT02816918
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2016-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extraluminal Use of the Bronchial Blocker of Univent Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2016-12-09', 'unreleaseDateUnknown': True}, {'releaseDate': '2016-12-21', 'unreleaseDateUnknown': True}, {'releaseDate': '2016-12-22', 'unreleaseDateUnknown': True}, {'releaseDate': '2017-02-14', 'unreleaseDateUnknown': True}, {'resetDate': '2017-04-04', 'releaseDate': '2017-02-20'}, {'resetDate': '2018-12-06', 'releaseDate': '2018-05-23'}, {'resetDate': '2023-11-22', 'releaseDate': '2023-02-14'}], 'estimatedResultsFirstSubmitDate': '2016-12-09'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-06', 'studyFirstSubmitDate': '2016-06-09', 'studyFirstSubmitQcDate': '2016-06-26', 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time for positioning', 'timeFrame': '15 min'}], 'secondaryOutcomes': [{'measure': 'frequency of malpositions', 'timeFrame': '5 min'}, {'measure': 'frequency of fiberoptic', 'timeFrame': '10 min'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Therapeutic Procedural Complication']}, 'descriptionModule': {'briefSummary': 'intends to evaluate the feasibility and security issues of univent bronchial blockers outside the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery patients.', 'detailedDescription': 'One-lung ventilation is desirable for Several clinical procedures, such as thoracic,pulmonary, and cardiac surgery to facilitate lung exposure for these surgical procedures by collapsing the lung and most commonly used device is the double-lumen tube (DLT) for this surgical procedures.Bronchial blockers (BBs), such as univent tube with an bronchial Blocker, has more advantages than the double-lumen tube: no need exchange tube when mechanical ventilation is required postoperative, easier insertion,less postoperative sore throat (ST) and hoarseness. However, BBs requires more time for placement and more difficult to position, especially patients undergoing left-side thoracic surgery. So, this study intends to evaluate the feasibility and security issues of univent bronchial blockers outside the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sixty patients undergoing left thoracic surgery\n* ASA classifications of I-II, modified Mallampati classification of 1 or 2, requiring general anesthesia were included.\n\nExclusion Criteria:\n\n* age younger than 18 yr or older than 70 yr\n* BMI\\>30 kg/m2\n* with upper respiratory tract infection,asthma\n* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions'}, 'identificationModule': {'nctId': 'NCT02816918', 'briefTitle': 'Extraluminal Use of the Bronchial Blocker of Univent Tube', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The First Hospital of Qinhuangdao'}, 'officialTitle': 'Extraluminal Use of the Bronchial Blocker of Univent Tube During Adult One-lung Ventilation', 'orgStudyIdInfo': {'id': '995866'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extraluminal use of Univent Blocker', 'description': "Patients assigned to the Extraluminal use of Univent Blocker group were first inserted Univent bronchial Blocker into the glottis via direct laryngoscopy then advanced the Blocker to the target bronchus until slight resistance was encountered.A conventional tracheal tube with appropriate size was intubated via direct laryngoscopy into the appropriate depth, inflating the tracheal tube cuff, and fixing the tube firmly at the patient's mouth with cloth tape .\n\nSo the Univent Blocker Extraluminal of the endotracheal tube,then the fibreoptic bronchoscopy was inserted into the tracheal tube and guided bronchial blocker cuff to the target main bronchus under direct vision", 'interventionNames': ['Device: Extraluminal use of Univent bronchial Blocker']}, {'type': 'EXPERIMENTAL', 'label': 'Innerluminal use of Univent Blocker', 'description': "Patients in Innerluminal use of Univent Blocker group: When the endotracheal tube had been intubated via direct laryngoscopy, the bronchial blocker was advanced Innerluminal of the endotracheal tube and directed into the right or left mainstem bronchus, then the fibreoptic bronchoscopy was inserted into the tracheal tube. After further pushing and twisting, the bronchial blocker tube will move into the mainstem bronchus under direct vision by FOB.the tracheal tube cuff is inflated with the tube being fixed firmly at the patient's mouth with cloth tape", 'interventionNames': ['Device: Innerluminal use Univent bronchial Blocker']}], 'interventions': [{'name': 'Extraluminal use of Univent bronchial Blocker', 'type': 'DEVICE', 'description': "Patients assigned to the Extraluminal use of Univent Blocker group were first inserted Univent bronchial Blocker into the glottis via direct laryngoscopy then advanced the Blocker to the target bronchus until slight resistance was encountered.A conventional tracheal tube with appropriate size was intubated via direct laryngoscopy into the appropriate depth, inflating the tracheal tube cuff, and fixing the tube firmly at the patient's mouth with cloth tape .\n\nSo the Univent Blocker Extraluminal of the endotracheal tube,then the fibreoptic bronchoscopy was inserted into the tracheal tube and guided bronchial blocker cuff to the target main bronchus under direct vision", 'armGroupLabels': ['Extraluminal use of Univent Blocker']}, {'name': 'Innerluminal use Univent bronchial Blocker', 'type': 'DEVICE', 'description': "Patients in Innerluminal use of Univent Blocker group: When the endotracheal tube had been intubated via direct laryngoscopy, the bronchial blocker was advanced Innerluminal of the endotracheal tube and directed into the right or left mainstem bronchus, then the fibreoptic bronchoscopy was inserted into the tracheal tube. After further pushing and twisting, the bronchial blocker tube will move into the mainstem bronchus under direct vision by FOB.the tracheal tube cuff is inflated with the tube being fixed firmly at the patient's mouth with cloth tape", 'armGroupLabels': ['Innerluminal use of Univent Blocker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '066000', 'city': 'Qinhuangdao', 'state': 'Hebei', 'country': 'China', 'facility': '中国', 'geoPoint': {'lat': 39.94104, 'lon': 119.58936}}], 'overallOfficials': [{'name': 'Ximing Qi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Hospital of Qinhuangdao'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Qinhuangdao', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-12-09', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2016-12-21', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2016-12-22', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2017-02-14', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2017-02-20', 'type': 'RELEASE'}, {'date': '2017-04-04', 'type': 'RESET'}, {'date': '2018-05-23', 'type': 'RELEASE'}, {'date': '2018-12-06', 'type': 'RESET'}, {'date': '2023-02-14', 'type': 'RELEASE'}, {'date': '2023-11-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'The First Hospital of Qinhuangdao'}}}}