Lung Cancer PatientsNCT07024433
Tubeless Anesthesia in Preventing Lung Complications in Patients Undergoing Surgery for Early-Stage Lung Cancer
A study testing Tubeless anesthesia and Traditional tracheal intubation in people with Lung Cancer Patients, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
The study focuses on evaluating the effectiveness and safety of tubeless anesthesia in single-port thoracoscopic surgery for early-stage lung cancer patients. Traditional anesthesia methods risk postoperative complications like lung injury and respiratory issues. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer Patients
- What is being tested?
- Tubeless anesthesia and Traditional tracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2025to 3 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years and ≤70 years;
- ECOG performance status score 0-1;
- Good cardiac and pulmonary function;
- Single or multiple peripheral lung nodules planned for single-port thoracoscopic surgery, with or without mediastinal lymph node dissection or sampling;
- Able to comply with the study visit schedule and other protocol requirements;
- Signed informed consent and voluntary participation in the study.
Who cannot join
- Obese patients (BMI >30);
- Patients with difficult intubation or expected complex airway management;
- COPD patients with copious airway secretions;
- Patients with neurological dysfunction or who cannot cooperate while awake;
- Patients expected to have extensive pleural adhesions or with previous lung resection;
- Elderly and frail patients with severe hypoxia (PaO2 <60 mmHg) or hypercapnia (PaCO2 >50/55 mmHg);
Show all 10Show fewer
- Previous induction chemotherapy or chemoradiotherapy;
- Intraoperative need to isolate the lung to prevent spillage and contamination of the contralateral lung;
- Patients expected to have large surgical wounds and lengthy procedures, clinically assessed as unsuitable;
- Patients whose cardiac and pulmonary function, or overall health, cannot withstand the procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Xiaodong Xu, +86-18359185681, chenandi1997@163.com
About this study
Official title: Tubeless Anesthesia in Preventing Contralateral Lung Complications in Patients Undergoing Single-Port Thoracoscopic Surgery for Early-Stage Lung Cancer: A Single-Center, Prospective, Open-Label, Randomized Controlled Trial
The study focuses on evaluating the effectiveness and safety of tubeless anesthesia in single-port thoracoscopic surgery for early-stage lung cancer patients. Traditional anesthesia methods risk postoperative complications like lung injury and respiratory issues. Tubeless anesthesia preserves spontaneous breathing without tracheal intubation, potentially reducing these complications and enhancing recovery. The study aims to compare this technique with traditional methods, assessing its impact on contralateral lung complications, perioperative hemodynamics, complication rates, and recovery speed.
Read the detailed description
With changes in lifestyle and environment, the incidence of early-stage lung cancer has been increasing annually. Traditional open surgical treatments have drawbacks such as significant trauma and noticeable pain, which has led to increased interest in minimally invasive surgery. In recent years, with continuous advancements in technology, single-port thoracoscopic surgery has become a popular choice for minimally invasive procedures, offering advantages such as minimal intraoperative trauma, mild postoperative pain, and good cosmetic results. However, traditional tracheal intubation and mechanical ventilation carry a range of potential side effects, including pressure-induced injury, lung overdistension, and the release of various pro-inflammatory mediators. Additionally, ventilator-associated lung injury occurs in about 4% of patients undergoing lung resection, with a mortality rate reaching up to 25%. The possibility of subclinical lung injury may also be underestimated. Furthermore, orotracheal and bronchial intubation can lead to various local complications, including upper respiratory tract pain, mucosal ulcers, and injury to the larynx or trachea. General anesthesia might have harmful systemic side effects, whereas local anesthesia does not pose such issues for awake patients or those with minimal sedation. Moreover, the use of muscle relaxants can lead to diaphragmatic dysfunction and atelectasis. Intravenous analgesics, especially opioids, are associated with postoperative vomiting, nausea, and respiratory depression. Importantly, postoperative pulmonary complications are among the most common complications following such surgeries, including atelectasis, lung infections, and pleural effusions, which can severely affect patient recovery and even be life-threatening. Therefore, it is crucial to find an anesthesia technique that ensures surgical efficacy while reducing postoperative pulmonary complications.
Tubeless anesthesia, which implies retaining spontaneous breathing without tracheal intubation, refers to a general anesthesia technique that does not involve tracheal intubation during thoracoscopic surgery. It employs airway devices that do not invade the trachea, alongside regional anesthesia and intravenous sedation and analgesics, to preserve spontaneous breathing. As a new anesthetic technique emerging in recent years, it offers several advantages over traditional methods, such as faster recovery, alignment with the needs of minimally invasive surgery, and a reduction in postoperative complications. Currently, the reported application range of tubeless anesthesia is extensive, encompassing simple lung biopsies, bullectomies, treatments for hyperhidrosis, as well as wedge resections, lobectomies, segmentectomies, and mediastinal tumor surgeries, even including complex tracheal tumor resections and carina reconstructions. The surgical approaches include multipoint and single-port procedures, as well as Da Vinci robotic surgeries. Although retrospective studies have confirmed the feasibility, safety, and efficacy of tubeless anesthesia in thoracoscopic-assisted minimally invasive surgery, the focus has predominantly been on the occurrence of ipsilateral lung complications.
Currently, reports on the preventive value and safety of this technique for contralateral lung complications in single-port thoracoscopic surgery in early-stage lung cancer patients are scarce, and prospective research evidence is lacking. Therefore, the primary aim of this study is to apply tubeless anesthesia in single-port thoracoscopic surgery for early-stage lung cancer patients, and to compare the incidence of contralateral lung complications three days postoperatively, perioperative hemodynamics, perioperative complication rates, and recovery speed with patients having similar baseline conditions who underwent traditional single-lumen tube + blocking tube or double-lumen tracheal intubation general anesthesia, to verify its clinical value.
- Conditions
- Lung Cancer Patients
- Being tested
- Tubeless anesthesia, Traditional tracheal intubation
- Keywords
- Early-stage lung cancer, Tubeless anesthesia, Single-port thoracoscopic surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubeless anesthesiaProcedure or surgery
- Anesthesia Induction: Implement TCI with propofol and remifentanil; insert a laryngeal mask for SIMV ventilation, and monitor vital signs including IBP and end-tidal CO2.
- Nerve Blocks: Perform ultrasound-guided paravertebral, pleural surface, and vagus nerve blocks using local anesthetics.
- Anesthesia Maintenance: Adjust remifentanil for spontaneous breathing; maintain propofol and BIS levels; manage heart rate and blood pressure with fluids and medication as needed, without using inhaled anesthetics.
- Postoperative Analgesia: Provide PCIA with morphine for pain management.
Traditional tracheal intubationProcedure or surgery
- Anesthesia induction using propofol, sufentanil, and rocuronium is performed, with DLT or single-lumen tube insertion at BIS≤60 for single-lung ventilation, maintaining appropriate oxygen and ventilation parameters.
- Anesthesia is maintained with sevoflurane, propofol, and remifentanil, supplementing rocuronium every 30-40 minutes for muscle relaxation, with BIS maintained at 40-60.
- Post-surgery, ultrasound-guided thoracic paravertebral block and PCIA are used for analgesia, with extubation following standard recovery procedures.
| Study group | Role | What they receive |
|---|---|---|
| Control group (traditional tracheal intubation group) | Other | 1. Anesthesia induction using propofol, sufentanil, and rocuronium is performed, with DLT or single-lumen tube insertion at BIS≤60 for single-lung ventilation, maintaining appropriate oxygen and ventilation parameters.
2. Anesthesia is maintained with sevoflurane, propofol, and remifentanil, supplementing rocuronium every 30-40 minutes for muscle relaxation, with BIS maintained at 40-60.
3. Post-surgery, ultrasound-guided thoracic paravertebral block and PCIA are used for analgesia, with extubation following standard recovery procedures. Receives: Procedure: Traditional tracheal intubation |
| Experimental group (Tubeless anesthesia group) | Experimental | 1. Anesthesia Induction: Implement TCI with propofol and remifentanil; insert a laryngeal mask for SIMV ventilation, and monitor vital signs including IBP and end-tidal CO2.
2. Nerve Blocks: Perform ultrasound-guided paravertebral, pleural surface, and vagus nerve blocks using local anesthetics.
3. Anesthesia Maintenance: Adjust remifentanil for spontaneous breathing; maintain propofol and BIS levels; manage heart rate and blood pressure with fluids and medication as needed, without using inhaled anesthetics.
4. Postoperative Analgesia: Provide PCIA with morphine for pain management. Receives: Procedure: Tubeless anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contralateral lung complications
This measure will determine the number of patients experiencing complications in the contralateral lung, as diagnosed through chest X-rays, within three days following surgery.
Measured: 3 days after surgery
Secondary outcomes (5)
Intraoperative hemodynamic analysis
Hemodynamic stability is monitored through three physiological parameters: heart rate (beats per minute), systolic blood pressure, and diastolic blood pressure (mmHg). During the surgery, these measurements are taken every 15 minutes, and the results for each parameter are reported in their respective units.
Measured: During surgery
Intraoperative Blood Gas Analysis
This measurement includes arterial blood gas analysis, comprising pH value, partial pressure of oxygen (PaO2 [mmHg]), partial pressure of carbon dioxide (PaCO2 [mmHg]), and bicarbonate levels (HCO3- [mmol/L]). Measurements are taken once at the beginning and once at the end of the surgery.
Measured: The beginning and once at the end of the surgery.
Consumption of Anesthetics and Vasoactive Drugs
The total consumption of anesthetics (measured in mg) and vasoactive drugs (measured in micrograms per kilogram per minute [mcg/kg/min]) will be documented. The data will reflect the total dosage administered during the perioperative period.
Measured: During surgery
Visual Analogue Scale (VAS) for Pain Assessment
Pain levels will be evaluated using the Visual Analogue Scale, which ranges from 0 (no pain) to 10 (worst possible pain). Data will be collected postoperatively and presented as an average score.
Measured: After surgery
Incidence of Other Adverse Reactions
Any additional adverse reactions will be recorded and categorized. The data will be presented as the number of patients experiencing specific adverse effects, along with their frequency.
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start25 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion3 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024433
- Sponsor's protocol ID
- 2024YF068-01
- Status last verified
- Apr 2025
- First submitted
- 29 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In compliance with confidentiality requirements and to ensure the privacy of our participants, Individual Participant Data (IPD) from this clinical trial will not be shared publicly. This decision ensures adherence to ethical guidelines and legal standards for data protection, safeguarding the personal information and privacy of all participants involved in the study
Publications
Liu Y, Liang L, Yang H. Airway management in "tubeless" spontaneous-ventilation video-assisted thoracoscopic tracheal surgery: a retrospective observational case series study. J Cardiothorac Surg. 2023 Feb 4;18(1):59. doi: 10.1186/s13019-023-02157-w.
PubMed 36737801Cui 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 27621880Kim HJ, Kim M, Park B, Park YH, Min SH. Feasibility of ventilator-assisted tubeless anesthesia for video-assisted thoracoscopic surgery. Medicine (Baltimore). 2023 Jul 14;102(28):e34220. doi: 10.1097/MD.0000000000034220.
PubMed 37443490Shao GQ, Pang DZ, Zhang JT, Wang HX, Liuru TY, Liu ZH, Liang YN, Liu JS. Spontaneous ventilation anesthesia combined with uniportal and tubeless thoracoscopic sympathectomy in selected patients with primary palmar hyperhidrosis. J Cardiothorac Surg. 2022 Jul 15;17(1):177. doi: 10.1186/s13019-022-01917-4.
PubMed 35840969Liu CY, Hsu PK, Leong KI, Ting CK, Tsou MY. Is tubeless uniportal video-assisted thoracic surgery for pulmonary wedge resection a safe procedure? Eur J Cardiothorac Surg. 2020 Aug 1;58(Suppl_1):i70-i76. doi: 10.1093/ejcts/ezaa061.
PubMed 32182334Yang LQ, Zhu L, Shi X, Miao CH, Yuan HB, Liu ZQ, Gu WD, Liu F, Hu XX, Shi DP, Duan HW, Wang CY, Weng H, Huang ZL, Li LZ, He ZZ, Li J, Hu YP, Lin L, Pan ST, Xu SH, Tang D, Sessler DI, Liu J, Irwin MG, Yu WF; POLMA-EP investigators. Postoperative pulmonary complications in older patients undergoing elective surgery with a supraglottic airway device or tracheal intubation. Anaesthesia. 2023 Aug;78(8):953-962. doi: 10.1111/anae.16030. Epub 2023 Jun 4.
PubMed 37270923Harris M, Chung F. Complications of general anesthesia. Clin Plast Surg. 2013 Oct;40(4):503-13. doi: 10.1016/j.cps.2013.07.001. Epub 2013 Aug 1.
PubMed 24093647Mullan GP, Georgalas C, Arora A, Narula A. Conservative management of a major post-intubation tracheal injury and review of current management. Eur Arch Otorhinolaryngol. 2007 Jun;264(6):685-8. doi: 10.1007/s00405-006-0234-4. Epub 2007 Mar 23.
PubMed 17380343Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
PubMed 34597688Sakuraya M, Okano H, Masuyama T, Kimata S, Hokari S. Efficacy of non-invasive and invasive respiratory management strategies in adult patients with acute hypoxaemic respiratory failure: a systematic review and network meta-analysis. Crit Care. 2021 Nov 29;25(1):414. doi: 10.1186/s13054-021-03835-8.
PubMed 34844655Ko KJ, Lee KS. Current surgical management of pelvic organ prolapse: Strategies for the improvement of surgical outcomes. Investig Clin Urol. 2019 Nov;60(6):413-424. doi: 10.4111/icu.2019.60.6.413. Epub 2019 Oct 29.
PubMed 31692921Ichinose J, Hashimoto K, Matsuura Y, Nakao M, Okumura S, Mun M. Risk factors for bronchopleural fistula after lobectomy for lung cancer. J Thorac Dis. 2023 Jun 30;15(6):3330-3338. doi: 10.21037/jtd-22-1809. Epub 2023 Jun 5.
PubMed 37426169
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tubeless Anesthesia in Preventing Contralateral Lung Complications in Patients Undergoing Single-Port Thoracoscopic Surgery for Early-Stage Lung Cancer: A Single-Center, Prospective, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07024433
- Acronym / sponsor ID
- 2024YF068-01
- Conditions
- Lung Cancer Patients
- Keywords
- Early-stage lung cancer, Tubeless anesthesia, Single-port thoracoscopic surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 3 Dec 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- 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.
The study focuses on evaluating the effectiveness and safety of tubeless anesthesia in single-port thoracoscopic surgery for early-stage lung cancer patients. Traditional anesthesia methods risk postoperative complications like lung injury and respiratory issues. Tubeless anesthesia preserves spontaneous breathing without tracheal intubation, potentially reducing these complications and enhancing recovery. The study aims to compare this technique with traditional methods, assessing its impact on contralateral lung complications, perioperative hemodynamics, complication rates, and recovery speed.
Detailed description
With changes in lifestyle and environment, the incidence of early-stage lung cancer has been increasing annually. Traditional open surgical treatments have drawbacks such as significant trauma and noticeable pain, which has led to increased interest in minimally invasive surgery. In recent years, with continuous advancements in technology, single-port thoracoscopic surgery has become a popular choice for minimally invasive procedures, offering advantages such as minimal intraoperative trauma, mild postoperative pain, and good cosmetic results. However, traditional tracheal intubation and mechanical ventilation carry a range of potential side effects, including pressure-induced injury, lung overdistension, and the release of various pro-inflammatory mediators. Additionally, ventilator-associated lung injury occurs in about 4% of patients undergoing lung resection, with a mortality rate reaching up to 25%. The possibility of subclinical lung injury may also be underestimated. Furthermore, orotracheal and bronchial intubation can lead to various local complications, including upper respiratory tract pain, mucosal ulcers, and injury to the larynx or trachea. General anesthesia might have harmful systemic side effects, whereas local anesthesia does not pose such issues for awake patients or those with minimal sedation. Moreover, the use of muscle relaxants can lead to diaphragmatic dysfunction and atelectasis. Intravenous analgesics, especially opioids, are associated with postoperative vomiting, nausea, and respiratory depression. Importantly, postoperative pulmonary complications are among the most common complications following such surgeries, including atelectasis, lung infections, and pleural effusions, which can severely affect patient recovery and even be life-threatening. Therefore, it is crucial to find an anesthesia technique that ensures surgical efficacy while reducing postoperative pulmonary complications.
Tubeless anesthesia, which implies retaining spontaneous breathing without tracheal intubation, refers to a general anesthesia technique that does not involve tracheal intubation during thoracoscopic surgery. It employs airway devices that do not invade the trachea, alongside regional anesthesia and intravenous sedation and analgesics, to preserve spontaneous breathing. As a new anesthetic technique emerging in recent years, it offers several advantages over traditional methods, such as faster recovery, alignment with the needs of minimally invasive surgery, and a reduction in postoperative complications. Currently, the reported application range of tubeless anesthesia is extensive, encompassing simple lung biopsies, bullectomies, treatments for hyperhidrosis, as well as wedge resections, lobectomies, segmentectomies, and mediastinal tumor surgeries, even including complex tracheal tumor resections and carina reconstructions. The surgical approaches include multipoint and single-port procedures, as well as Da Vinci robotic surgeries. Although retrospective studies have confirmed the feasibility, safety, and efficacy of tubeless anesthesia in thoracoscopic-assisted minimally invasive surgery, the focus has predominantly been on the occurrence of ipsilateral lung complications.
Currently, reports on the preventive value and safety of this technique for contralateral lung complications in single-port thoracoscopic surgery in early-stage lung cancer patients are scarce, and prospective research evidence is lacking. Therefore, the primary aim of this study is to apply tubeless anesthesia in single-port thoracoscopic surgery for early-stage lung cancer patients, and to compare the incidence of contralateral lung complications three days postoperatively, perioperative hemodynamics, perioperative complication rates, and recovery speed with patients having similar baseline conditions who underwent traditional single-lumen tube + blocking tube or double-lumen tracheal intubation general anesthesia, to verify its clinical value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (traditional tracheal intubation group) | Other | Procedure: Traditional tracheal intubation1. Anesthesia induction using propofol, sufentanil, and rocuronium is performed, with DLT or single-lumen tube insertion at BIS≤60 for single-lung ventilation, maintaining appropriate oxygen and ventilation parameters. 2. Anesthesia is maintained with sevoflurane, propofol, and remifentanil, supplementing rocuronium every 30-40 minutes for muscle relaxation, with BIS maintained at 40-60. 3. Post-surgery, ultrasound-guided thoracic paravertebral block and PCIA are used for analgesia, with extubation following standard recovery procedures. |
| Experimental group (Tubeless anesthesia group) | Experimental | Procedure: Tubeless anesthesia1. Anesthesia Induction: Implement TCI with propofol and remifentanil; insert a laryngeal mask for SIMV ventilation, and monitor vital signs including IBP and end-tidal CO2. 2. Nerve Blocks: Perform ultrasound-guided paravertebral, pleural surface, and vagus nerve blocks using local anesthetics. 3. Anesthesia Maintenance: Adjust remifentanil for spontaneous breathing; maintain propofol and BIS levels; manage heart rate and blood pressure with fluids and medication as needed, without using inhaled anesthetics. 4. Postoperative Analgesia: Provide PCIA with morphine for pain management. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years and ≤70 years;
- ECOG performance status score 0-1;
- Good cardiac and pulmonary function;
- Single or multiple peripheral lung nodules planned for single-port thoracoscopic surgery, with or without mediastinal lymph node dissection or sampling;
- Able to comply with the study visit schedule and other protocol requirements;
Key exclusion criteria (10 listed)
- Obese patients (BMI >30);
- Patients with difficult intubation or expected complex airway management;
- COPD patients with copious airway secretions;
- Patients with neurological dysfunction or who cannot cooperate while awake;
- Patients expected to have extensive pleural adhesions or with previous lung resection;
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 |
|---|---|---|
| Tubeless anesthesia1. Anesthesia Induction: Implement TCI with propofol and remifentanil; insert a laryngeal mask for SIMV ventilation, and monitor vital signs including IBP and end-tidal CO2. 2. Nerve Blocks: Perform ultrasound-guided paravertebral, pleural surface, and vagus nerve blocks using local anesthetics. 3. Anesthesia Maintenance: Adjust remifentanil for spontaneous breathing; maintain propofol and BIS levels; manage heart rate and blood pressure with fluids and medication as needed, without using inhaled anesthetics. 4. Postoperative Analgesia: Provide PCIA with morphine for pain management. | Procedure or surgery | Experimental group (Tubeless anesthesia group) |
| Traditional tracheal intubation1. Anesthesia induction using propofol, sufentanil, and rocuronium is performed, with DLT or single-lumen tube insertion at BIS≤60 for single-lung ventilation, maintaining appropriate oxygen and ventilation parameters. 2. Anesthesia is maintained with sevoflurane, propofol, and remifentanil, supplementing rocuronium every 30-40 minutes for muscle relaxation, with BIS maintained at 40-60. 3. Post-surgery, ultrasound-guided thoracic paravertebral block and PCIA are used for analgesia, with extubation following standard recovery procedures. | Procedure or surgery | Control group (traditional tracheal intubation group) |
Primary outcome
Contralateral lung complications
Time frame: 3 days after surgery
This measure will determine the number of patients experiencing complications in the contralateral lung, as diagnosed through chest X-rays, within three days following surgery.
5 secondary outcomes
Intraoperative hemodynamic analysis
Time frame: During surgery
Intraoperative Blood Gas Analysis
Time frame: The beginning and once at the end of the surgery.
Consumption of Anesthetics and Vasoactive Drugs
Time frame: During surgery
Visual Analogue Scale (VAS) for Pain Assessment
Time frame: After surgery
Incidence of Other Adverse Reactions
Time frame: Perioperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Background: PubMed 36737801Liu Y, Liang L, Yang H. Airway management in "tubeless" spontaneous-ventilation video-assisted thoracoscopic tracheal surgery: a retrospective observational case series study. J Cardiothorac Surg. 2023 Feb 4;18(1):59. doi: 10.1186/s13019-023-02157-w.
- 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 37443490Kim HJ, Kim M, Park B, Park YH, Min SH. Feasibility of ventilator-assisted tubeless anesthesia for video-assisted thoracoscopic surgery. Medicine (Baltimore). 2023 Jul 14;102(28):e34220. doi: 10.1097/MD.0000000000034220.
- Background: PubMed 35840969Shao GQ, Pang DZ, Zhang JT, Wang HX, Liuru TY, Liu ZH, Liang YN, Liu JS. Spontaneous ventilation anesthesia combined with uniportal and tubeless thoracoscopic sympathectomy in selected patients with primary palmar hyperhidrosis. J Cardiothorac Surg. 2022 Jul 15;17(1):177. doi: 10.1186/s13019-022-01917-4.
- Background: PubMed 32182334Liu CY, Hsu PK, Leong KI, Ting CK, Tsou MY. Is tubeless uniportal video-assisted thoracic surgery for pulmonary wedge resection a safe procedure? Eur J Cardiothorac Surg. 2020 Aug 1;58(Suppl_1):i70-i76. doi: 10.1093/ejcts/ezaa061.
- Background: PubMed 37270923Yang LQ, Zhu L, Shi X, Miao CH, Yuan HB, Liu ZQ, Gu WD, Liu F, Hu XX, Shi DP, Duan HW, Wang CY, Weng H, Huang ZL, Li LZ, He ZZ, Li J, Hu YP, Lin L, Pan ST, Xu SH, Tang D, Sessler DI, Liu J, Irwin MG, Yu WF; POLMA-EP investigators. Postoperative pulmonary complications in older patients undergoing elective surgery with a supraglottic airway device or tracheal intubation. Anaesthesia. 2023 Aug;78(8):953-962. doi: 10.1111/anae.16030. Epub 2023 Jun 4.
- Background: PubMed 24093647Harris M, Chung F. Complications of general anesthesia. Clin Plast Surg. 2013 Oct;40(4):503-13. doi: 10.1016/j.cps.2013.07.001. Epub 2013 Aug 1.
- Background: PubMed 17380343Mullan GP, Georgalas C, Arora A, Narula A. Conservative management of a major post-intubation tracheal injury and review of current management. Eur Arch Otorhinolaryngol. 2007 Jun;264(6):685-8. doi: 10.1007/s00405-006-0234-4. Epub 2007 Mar 23.
- Background: PubMed 34597688Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
- Background: PubMed 34844655Sakuraya M, Okano H, Masuyama T, Kimata S, Hokari S. Efficacy of non-invasive and invasive respiratory management strategies in adult patients with acute hypoxaemic respiratory failure: a systematic review and network meta-analysis. Crit Care. 2021 Nov 29;25(1):414. doi: 10.1186/s13054-021-03835-8.
- Background: PubMed 31692921Ko KJ, Lee KS. Current surgical management of pelvic organ prolapse: Strategies for the improvement of surgical outcomes. Investig Clin Urol. 2019 Nov;60(6):413-424. doi: 10.4111/icu.2019.60.6.413. Epub 2019 Oct 29.
- Background: PubMed 37426169Ichinose J, Hashimoto K, Matsuura Y, Nakao M, Okumura S, Mun M. Risk factors for bronchopleural fistula after lobectomy for lung cancer. J Thorac Dis. 2023 Jun 30;15(6):3330-3338. doi: 10.21037/jtd-22-1809. Epub 2023 Jun 5.
- Individual participant dataSharing planned: No. In compliance with confidentiality requirements and to ensure the privacy of our participants, Individual Participant Data (IPD) from this clinical trial will not be shared publicly. This decision ensures adherence to ethical guidelines and legal standards for data protection, safeguarding the personal information and privacy of all participants involved in the study
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Non Small Cell Lung Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tubeless anesthesia and Traditional tracheal intubation in people with Lung Cancer Patients, run by Fujian Medical University Union Hospital at 1 site 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Jun 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shishi Huang (+81 18120825212, twolions1997@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contralateral lung complications (time frame: 3 days after surgery). 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 NCT07024433, 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 17 Jun 2025.