Stability During Surgical OperationPhase 3NCT03016858

Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia

A Phase 3 study testing Thoracoscopic Bullectomy Surgery in people with Stability During Surgical Operation and Complication, Postoperative, run by Guangzhou Institute of Respiratory Disease at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 16 to 50 years
Conditions the study is for: Stability During Surgical Operation, Complication, Postoperative, Postoperative Hospitalization Time
What is being tested?: Thoracoscopic Bullectomy Surgery
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 320 participants
Where: 1 siteChina
Study dates: Dec 2016to Dec 2019
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 50 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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%

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Fei Cui, Ph.D, M.D. contact

08618902301212 ext. 08602083062822

cuidavil@hotmail.com

China1 site, 1 recruiting

the First Affiliated Hospital of Guangzhou Medical university
Guangzhou, Guangdong, 510000
Fei Cui, MD.,PhD, 08618902301212, 4641121@qq.com
Recruiting

Other trials in China

About this study

Official title: Multicenter Randomized Controlled Clinical Trial of Thoracoscopic Bullectomy Surgery Under Nonintubated Intravenous Anesthesia With Spontaneous Ventilation

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.

Read the detailed description

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: Stability During Surgical Operation, Complication, Postoperative, Postoperative Hospitalization Time
Being tested: Thoracoscopic Bullectomy Surgery
Medical subject headings: Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Thoracoscopic Bullectomy SurgeryProcedure or surgery
Also called video-assisted thoracoscopic bulla resection
undergoing the Thoracoscopic Bullectomy Surgery

Study groups in NCT03016858
Study group	Role	What they receive
NIIASV	Experimental	undergoing Thoracoscopic Bullectomy Surgery under nonintubated intravenous anesthesia with spontaneous ventilation(NIIASV) Receives: Procedure: Thoracoscopic Bullectomy Surgery
IASLV	Active comparator	undergoing Thoracoscopic Bullectomy Surgery under intubated anesthesia with single-lung mechanical ventilation(IASLV) Receives: Procedure: Thoracoscopic Bullectomy Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

numbers of participants with postoperative respiratory and cardiovascular complications
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
Measured: from operation to discharging, an average of 1 week

Secondary outcomes (3)

numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively
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.
Measured: during the surgical operation, an average of 1 hour
numbers of participants with anesthesia conversion intraoperatively in nonintubated group
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.
Measured: during the surgical operation, an average of 1 hour
numbers of participants with postoperative complications
The numbers of participants with any postoperative complications will be reported.
Measured: from operation to discharging, an average of 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2016Dec 2019

First posted11 Jan 2017 (estimated)
Study startDec 2016
Primary completionMay 2019 (estimated)
Study completionDec 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Stability During Surgical OperationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 320 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03016858
Sponsor's protocol ID: SVA-001
Status last verified: Jan 2019
First submitted: 20 Dec 2016
Last updated: 29 Jan 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 27621880
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.
PubMed 27076956
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.
PubMed 27076955
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.
PubMed 26046043
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.
PubMed 25937782
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.
PubMed 22833817
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.
PubMed 27165771
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.
PubMed 27165732
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.
PubMed 24821259
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.
PubMed 21869676
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.
PubMed 32395294

Want to know more?

Fei Cui, Ph.D, M.D.

08618902301212 ext. 08602083062822

cuidavil@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stability During Surgical Operation trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Randomized Controlled Clinical Trial of Thoracoscopic Bullectomy Surgery Under Nonintubated Intravenous Anesthesia With Spontaneous Ventilation
ClinicalTrials.gov ID: NCT03016858
Acronym / sponsor ID: SVA-001
Conditions: Stability During Surgical Operation, Complication, Postoperative, Postoperative Hospitalization Time
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 320 participants (estimated)
Lead sponsor: Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
Collaborators: First Affiliated Hospital, Sun Yat-Sen University, Taizhou Hospital, The Second Hospital University of South China, Affiliated Hospital of Southwest Medical University, Nanfang Hospital, Southern Medical University, Shenzhen Third People's Hospital, Jieyang People's Hospital
Study start: Dec 2016
Primary completion: May 2019 (estimated)
Study completion: Dec 2019 (estimated)
First posted: 11 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
NIIASV	Experimental	Procedure: Thoracoscopic Bullectomy Surgeryundergoing Thoracoscopic Bullectomy Surgery under nonintubated intravenous anesthesia with spontaneous ventilation(NIIASV)
IASLV	Active comparator	Procedure: Thoracoscopic Bullectomy Surgeryundergoing Thoracoscopic Bullectomy Surgery under intubated anesthesia with single-lung mechanical ventilation(IASLV)

Who may qualify

Ages: 16 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Thoracoscopic Bullectomy SurgeryAlso: video-assisted thoracoscopic bulla resectionundergoing the Thoracoscopic Bullectomy Surgery	Procedure or surgery	IASLV, NIIASV

Primary outcome

numbers of participants with postoperative respiratory and cardiovascular complications
Time frame: from operation to discharging, an average of 1 week
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

3 secondary outcomes

numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively
Time frame: during the surgical operation, an average of 1 hour
numbers of participants with anesthesia conversion intraoperatively in nonintubated group
Time frame: during the surgical operation, an average of 1 hour
numbers of participants with postoperative complications
Time frame: from operation to discharging, an average of 1 week

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
Background: PubMed 27621880Cui 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.
Background: PubMed 27076956Peng 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.
Background: PubMed 27076955Li 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.
Background: PubMed 26046043Liu 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.
Background: PubMed 25937782Li 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.
Background: PubMed 22833817Dong 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.
Background: PubMed 27165771Liu 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.
Background: PubMed 27165732Guo 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.
Background: PubMed 24821259Liu 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.
Background: PubMed 21869676Chen 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.
Derived from this study: PubMed 32395294Cui 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fei Cui, Ph.D, M.D. contact

08618902301212 ext. 08602083062822

cuidavil@hotmail.com

Jun Liu, Ph.D, M.D. study chair

The First Affiliated Hospital of Guangzhou Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fei Cui, Ph.D, M.D. (08618902301212 ext. 08602083062822, cuidavil@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

numbers of participants with postoperative respiratory and cardiovascular complications (time frame: from operation to discharging, an average of 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03016858, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.