Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2026-02-25 @ 3:36 AM
Study NCT ID:
NCT03016858
Status:
UNKNOWN
Last Update Posted:
2019-01-29
First Post:
2016-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-27', 'studyFirstSubmitDate': '2016-12-20', 'studyFirstSubmitQcDate': '2017-01-08', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'the postoperative hospitalization time of every participant', 'timeFrame': 'through the postoperative hospitalization time, an average of 1 week)', 'description': 'the postoperative time point of participants meeting the discharging criteria: body T°\\<37.5℃, degree of blood oxygen saturation on room air\\>95%, no complications requiring in-hospital treatment, full lung re-expansion after chest tube removal, and white blood cell count\\<10×109/L.'}], 'primaryOutcomes': [{'measure': 'numbers of participants with postoperative respiratory and cardiovascular complications', 'timeFrame': 'from operation to discharging, an average of 1 week', 'description': 'The numbers of participants with postoperative respiratory and cardiovascular complications will be reported. The postoperative complications include postoperative respiratory complications(e.g., air leaks, lung infections, atelectasis, and bronchospasm and respiratory failure), postoperative cardiovascular complications(e.g., arrhythmias, myocardial infarction, cardiac failure) , intubated related complications(e.g., hoarseness, sore throat, and irritating cough), and other undefined complications'}], 'secondaryOutcomes': [{'measure': 'numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively', 'timeFrame': 'during the surgical operation, an average of 1 hour', 'description': 'the numbers of participants with unstable vital signs or hypoxemia/hypercapnia will be reported. The vital signs will be monitored through the whole surgical operation(including heart rating in beat per minute, temperature in degree Celsius, respiratory in breaths per minute and blood pressure in oxygen in millimetres of mercury ), and blood gas analysis((including partial pressure of oxygen in millimetres of mercury, partial pressure of carbon dioxide in millimetres of mercury, and so on) will be tested every 30 mins during the operation.'}, {'measure': 'numbers of participants with anesthesia conversion intraoperatively in nonintubated group', 'timeFrame': 'during the surgical operation, an average of 1 hour', 'description': 'The numbers of participants undergoing conversion from nonintubated anaesthesia to intubated anaesthesia in nonintubated group will be reported because of hypoxemia, carbohemia, bleeding or other undefined reasons.'}, {'measure': 'numbers of participants with postoperative complications', 'timeFrame': 'from operation to discharging, an average of 1 week', 'description': 'The numbers of participants with any postoperative complications will be reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stability During Surgical Operation', 'Complication, Postoperative', 'Postoperative Hospitalization Time']}, 'referencesModule': {'references': [{'pmid': '27621880', 'type': 'BACKGROUND', 'citation': 'Cui F, Liu J, Li S, Yin W, Xin X, Shao W, He J. Tubeless video-assisted thoracoscopic surgery (VATS) under non-intubated, intravenous anesthesia with spontaneous ventilation and no placement of chest tube postoperatively. J Thorac Dis. 2016 Aug;8(8):2226-32. doi: 10.21037/jtd.2016.08.02.'}, {'pmid': '27076956', 'type': 'BACKGROUND', 'citation': 'Peng G, Cui F, Ang KL, Zhang X, Yin W, Shao W, Dong Q, Liang L, He J. Non-intubated combined with video-assisted thoracoscopic in carinal reconstruction. J Thorac Dis. 2016 Mar;8(3):586-93. doi: 10.21037/jtd.2016.01.58.'}, {'pmid': '27076955', 'type': 'BACKGROUND', 'citation': 'Li S, Liu J, He J, Dong Q, Liang L, Cui F, Pan H, He J. Video-assisted transthoracic surgery resection of a tracheal mass and reconstruction of trachea under non-intubated anesthesia with spontaneous breathing. J Thorac Dis. 2016 Mar;8(3):575-85. doi: 10.21037/jtd.2016.01.62.'}, {'pmid': '26046043', 'type': 'BACKGROUND', 'citation': 'Liu J, Cui F, He J. Non-intubated video-assisted thoracoscopic surgery anatomical resections: a new perspective for treatment of lung cancer. Ann Transl Med. 2015 May;3(8):102. doi: 10.3978/j.issn.2305-5839.2015.04.18.'}, {'pmid': '25937782', 'type': 'BACKGROUND', 'citation': 'Li S, Cui F, Liu J, Xu X, Shao W, Yin W, Chen H, He J. Nonintubated uniportal video-assisted thoracoscopic surgery for primary spontaneous pneumothorax. Chin J Cancer Res. 2015 Apr;27(2):197-202. doi: 10.3978/j.issn.1000-9604.2015.03.01.'}, {'pmid': '22833817', 'type': 'BACKGROUND', 'citation': 'Dong Q, Liang L, Li Y, Liu J, Yin W, Chen H, Xu X, Shao W, He J. Anesthesia with nontracheal intubation in thoracic surgery. J Thorac Dis. 2012 Apr 1;4(2):126-30. doi: 10.3978/j.issn.2072-1439.2012.03.10.'}, {'pmid': '27165771', 'type': 'BACKGROUND', 'citation': 'Liu J, Cui F, Pompeo E, Gonzalez-Rivas D, Chen H, Yin W, Shao W, Li S, Pan H, Shen J, Hamblin L, He J. The impact of non-intubated versus intubated anaesthesia on early outcomes of video-assisted thoracoscopic anatomical resection in non-small-cell lung cancer: a propensity score matching analysis. Eur J Cardiothorac Surg. 2016 Nov;50(5):920-925. doi: 10.1093/ejcts/ezw160. Epub 2016 May 10.'}, {'pmid': '27165732', 'type': 'BACKGROUND', 'citation': 'Guo Z, Yin W, Zhang X, Xu X, Liu H, Shao W, Liu J, Chen H, He J. Primary spontaneous pneumothorax: simultaneous treatment by bilateral non-intubated videothoracoscopy. Interact Cardiovasc Thorac Surg. 2016 Aug;23(2):196-201. doi: 10.1093/icvts/ivw123. Epub 2016 May 10.'}, {'pmid': '24821259', 'type': 'BACKGROUND', 'citation': 'Liu J, Cui F, Li S, Chen H, Shao W, Liang L, Yin W, Lin Y, He J. Nonintubated video-assisted thoracoscopic surgery under epidural anesthesia compared with conventional anesthetic option: a randomized control study. Surg Innov. 2015 Apr;22(2):123-30. doi: 10.1177/1553350614531662. Epub 2014 May 12.'}, {'pmid': '21869676', 'type': 'BACKGROUND', 'citation': 'Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b.'}, {'pmid': '32395294', 'type': 'DERIVED', 'citation': 'Cui F, Xu K, Liang H, Liang W, Li J, Wang W, Liu H, Liu J, He J. Spontaneous ventilation versus mechanical ventilation during video-assisted thoracoscopic surgery for spontaneous pneumothorax: a study protocol for multicenter randomized controlled trial. J Thorac Dis. 2020 Apr;12(4):1570-1581. doi: 10.21037/jtd.2020.02.13.'}]}, 'descriptionModule': {'briefSummary': 'With the development of video-assisted thoracoscopic surgery (VATS) techniques and technology for anesthesia control, non-intubated anesthesia with spontaneous ventilation has been widely applied in VATS. A multicenter randomized parallel controlled study was applied in this study to assess the efficacy and safety of thoracoscopic bullectomy surgery under intravenous anesthesia with spontaneous ventilation versus tracheal intubation general anesthesia.', 'detailedDescription': 'Intubated anesthesia with single lung mechanical ventilation (IASLV) is considered the standard of care in VATS. However, this type of anesthesia has been associated with several adverse effects, which can trigger complications and increase the overall surgical risk. In order to avoid intubated-anesthesia-related adverse effects, nonintubated strategies have been proposed in recent years.Encouraged by the satisfactory results with a preliminary experience of nonintubated VATS, the multicenter randomized parallel controlled study is established to comparatively analyze the outcome of patients undergoing either nonintubated intravenous anesthesia with spontaneous ventilation (NIIASV) or IASLV VATS thoracoscopic bullectomy surgery，especially in complication rate, safety during operation, muscle recovery after surgery, the difference the postoperative hospitalization time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* volunteering to participate in clinical trials and having the ability of responsibility can be signed informed consent.\n* 16-50 years old\n* preoperative chest CT diagnosed with "localized lung bulla" and needing surgical treatment\n* Eastern Cooperative Oncology Group(ECOG) score standard ≤ 1\n* ASA（American Society of Anesthesiologists score） ≤ 2\n* Heart ejection fraction( EF)≥ 50%\n\nExclusion Criteria:\n\n* refusing to participate in clinical trials\n* A history of tuberculosis or other diseases could cause pleural adhesion or more pleural effusion\n* BMI ≥ 25 kg/m\\^2\n* other not suitable situations'}, 'identificationModule': {'nctId': 'NCT03016858', 'briefTitle': 'Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Institute of Respiratory Disease'}, 'officialTitle': 'Multicenter Randomized Controlled Clinical Trial of Thoracoscopic Bullectomy Surgery Under Nonintubated Intravenous Anesthesia With Spontaneous Ventilation', 'orgStudyIdInfo': {'id': 'SVA-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIIASV', 'description': 'undergoing Thoracoscopic Bullectomy Surgery under nonintubated intravenous anesthesia with spontaneous ventilation(NIIASV)', 'interventionNames': ['Procedure: Thoracoscopic Bullectomy Surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IASLV', 'description': 'undergoing Thoracoscopic Bullectomy Surgery under intubated anesthesia with single-lung mechanical ventilation(IASLV)', 'interventionNames': ['Procedure: Thoracoscopic Bullectomy Surgery']}], 'interventions': [{'name': 'Thoracoscopic Bullectomy Surgery', 'type': 'PROCEDURE', 'otherNames': ['video-assisted thoracoscopic bulla resection'], 'description': 'undergoing the Thoracoscopic Bullectomy Surgery', 'armGroupLabels': ['IASLV', 'NIIASV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Cui, MD.,PhD', 'role': 'CONTACT', 'email': '4641121@qq.com', 'phone': '08618902301212'}], 'facility': 'the First Affiliated Hospital of Guangzhou Medical university', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Fei Cui, Ph.D, M.D.', 'role': 'CONTACT', 'email': 'cuidavil@hotmail.com', 'phone': '08618902301212', 'phoneExt': '08602083062822'}], 'overallOfficials': [{'name': 'Jun Liu, Ph.D, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Institute of Respiratory Disease', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Taizhou Hospital', 'class': 'OTHER'}, {'name': 'The Second Hospital University of South China', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Southwest Medical University', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': "Shenzhen Third People's Hospital", 'class': 'OTHER'}, {'name': "Jieyang People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jun Liu', 'investigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'}}}}