Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia

NCT ID: NCT03016858

Last Updated: 2019-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stability During Surgical Operation Complication, Postoperative Postoperative Hospitalization Time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NIIASV

undergoing Thoracoscopic Bullectomy Surgery under nonintubated intravenous anesthesia with spontaneous ventilation(NIIASV)

Group Type EXPERIMENTAL

Thoracoscopic Bullectomy Surgery

Intervention Type PROCEDURE

undergoing the Thoracoscopic Bullectomy Surgery

IASLV

undergoing Thoracoscopic Bullectomy Surgery under intubated anesthesia with single-lung mechanical ventilation(IASLV)

Group Type ACTIVE_COMPARATOR

Thoracoscopic Bullectomy Surgery

Intervention Type PROCEDURE

undergoing the Thoracoscopic Bullectomy Surgery

Interventions

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Thoracoscopic Bullectomy Surgery

undergoing the Thoracoscopic Bullectomy Surgery

Intervention Type PROCEDURE

Other Intervention Names

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video-assisted thoracoscopic bulla resection

Eligibility Criteria

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Inclusion Criteria

* volunteering to participate in clinical trials and having the ability of responsibility can be signed informed consent.
* 16-50 years old
* preoperative chest CT diagnosed with "localized lung bulla" and needing surgical treatment
* Eastern Cooperative Oncology Group(ECOG) score standard ≤ 1
* ASA(American Society of Anesthesiologists score) ≤ 2
* Heart ejection fraction( EF)≥ 50%

Exclusion Criteria

* refusing to participate in clinical trials
* A history of tuberculosis or other diseases could cause pleural adhesion or more pleural effusion
* BMI ≥ 25 kg/m\^2
* other not suitable situations
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Taizhou Hospital

OTHER

Sponsor Role collaborator

The Second Hospital University of South China

OTHER

Sponsor Role collaborator

Affiliated Hospital of Southwest Medical University

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Shenzhen Third People's Hospital

OTHER

Sponsor Role collaborator

Jieyang People's Hospital

OTHER

Sponsor Role collaborator

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role lead

Responsible Party

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Jun Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Liu, Ph.D, M.D.

Role: STUDY_CHAIR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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the First Affiliated Hospital of Guangzhou Medical university

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fei Cui, Ph.D, M.D.

Role: CONTACT

08618902301212 ext. 08602083062822

Facility Contacts

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Fei Cui, MD.,PhD

Role: primary

08618902301212

References

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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.

Reference Type BACKGROUND
PMID: 27621880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27076956 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27076955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26046043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25937782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22833817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27165771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27165732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24821259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21869676 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32395294 (View on PubMed)

Other Identifiers

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SVA-001

Identifier Type: -

Identifier Source: org_study_id

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