AzTrials
AzTrials

Non Small Cell Lung CancerPhase 3NCT03432637

Clinical Trial of Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia

A Phase 3 study testing spontaneous ventilation and intubated anesthesia with single-lung mechanical ventilation in people with Non Small Cell Lung Cancer, run by Guangzhou Institute of Respiratory Disease at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
spontaneous ventilation and intubated anesthesia with single-lung mechanical ventilation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
2 sitesChina
Study dates
5 Mar 2018to 31 Mar 2024
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • volunteering to participate in clinical trials and having the ability of responsibility can be signed informed consent.
  • 18-70 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 situation

Trial locations and contacts

2 sites in 1 country.

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

08618902301212 ext. 08602083062817

cuidavil@hotmail.com

China2 sites, 2 recruiting

  • the First Affiliated Hospital of Guangzhou Medical College

    Guangzhou, Guangdong, 510000

    Fei Cui, MD.,PhD, 08618902301212, 4641121@qq.com

    Recruiting

  • Fei Cui, Ph.D, M.D.

    Guangzhou, Guangdong, 510120

    Fei Cui, Ph.D, M.D., 08618902301212 ext. 08602083062817, cuidavil@hotmail.com

    Jun Liu, Ph.D, M.D., 08602013808880646, liujun9707@tom.com

    Recruiting

Other trials in China

About this study

Official title: Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia or Intubated Anesthesia: A Prospective, Multicentre, Open-label, Randomized Control Trial

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 prospective, multicentre, randomized controlled clinical study was applied in this study to assess the feasibility and safety of thoracoscopic lobectomy under spontaneous ventilation versus intubated single lung mechanical ventilation.

Read the detailed description

Intubated anesthesia with single lung mechanical ventilation (SLV) 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, spontaneous ventilation strategies have been proposed in recent years.Encouraged by the satisfactory results with a preliminary experience of spontaneous ventilated VATS, the multicentre randomized controlled clinical controled study is established to comparatively analyze the outcome of patients undergoing either nonintubated intravenous anesthesia with spontaneous ventilation (SV) or SLV VATS lobectomy, especially in safety during operation, lymph nodes resection, complication rate, muscle recovery after surgery, the difference the postoperative hospitalization time.

Being tested
spontaneous ventilation, intubated anesthesia with single-lung mechanical ventilation
Keywords
Complications, Postoperative/Perioperative, video assisted thoracic surgery, non-intubated anaesthesia
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • spontaneous ventilationProcedure or surgery

    thoracoscopic lobectomy under spontaneous ventilation

  • intubated anesthesia with single-lung mechanical ventilationProcedure or surgery

    undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation

Study groups in NCT03432637
Study groupRoleWhat they receive
SVExperimentalundergoing thoracoscopic lobectomy under spontaneous ventilation (SV)
Receives: Procedure: spontaneous ventilation
SLVActive comparatorundergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation(SLV)
Receives: Procedure: intubated anesthesia with single-lung mechanical ventilation

What is being measured

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

  1. 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

Secondary outcomes (2)

  1. numbers of participants with postoperative complications

    The numbers of participants with postoperative 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

  2. numbers of participants with anesthesia conversion intraoperatively in spontaneous ventilation group

    The numbers of participants undergoing conversion from nonintubated spontaneous ventilation 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

Timeline

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

  1. First posted14 Feb 2018
  2. Study start5 Mar 2018 (estimated)
  3. Primary completion31 Mar 2019 (estimated)
  4. Study completion31 Mar 2024 (estimated)

Resources

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
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03432637
Sponsor's protocol ID
SVA-NSCLC
Status last verified
Feb 2018
First submitted
31 Jan 2018
Last updated
26 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
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

  • Li S, Jiang L, Ang KL, Chen H, Dong Q, Yang H, Li J, He J. New tubeless video-assisted thoracoscopic surgery for small pulmonary nodules. Eur J Cardiothorac Surg. 2017 Apr 1;51(4):689-693. doi: 10.1093/ejcts/ezw364.

    PubMed 28007874

  • 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

  • Li J, Liu J, Hamblin L, Liu H, Liang L, Dong Q, He J. Simple to simplest: the tubeless technique. J Thorac Dis. 2017 Feb;9(2):222-224. doi: 10.21037/jtd.2017.02.55. No abstract available.

    PubMed 28275463

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing spontaneous ventilation and intubated anesthesia with single-lung mechanical ventilation in people with Non Small Cell Lung Cancer, run by Guangzhou Institute of Respiratory Disease at 2 sites in China.

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 4 inclusion and 3 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 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 08602083062817, 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 unstable vital signs, hypoxemia or hypercapnia intraoperatively (time frame: during the surgical operation, an average of 1 hour). 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 NCT03432637, which also lists 12 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 26 Feb 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in