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This study is a prospective, randomized, controlled study, which intends to enroll patients with suspected early-stage NSCLC (non-small cell lung cancer) with a diameter of ≤ 3 cm as research subjects. The study is conducted in accordance with the Declaration of Helsinki. It has been approved by the Ethics Committee of the Second Affiliated Hospital of Air Force Medical University, and patients or their family members have signed the informed consent form. Patients undergoing VATS (video-assisted thoracic surgery) are enrolled in the Department of Thoracic Surgery of the Second Affiliated Hospital of Air Force Medical University. The patients are randomly divided into two groups: the NIVATS (non-intubated video-assisted thoracic surgery) group and the OLV (one-lung ventilation) group. By observing various perioperative indicators of the patients, the short-term efficacy of the two techniques in patients with early-stage NSCLC is compared, so as to evaluate the safety and effectiveness of the NIVATS surgical treatment method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS) |
|
| group B | Placebo Comparator | Tracheal Intubation with One-Lung Ventilation Group (OLV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS) | Procedure | NIVATS is a special method developed in the past two decades. It means that patients do not undergo tracheal intubation under general anesthesia during the entire surgical process, retaining their spontaneous breathing, but supraglottic airway devices (such as laryngeal masks, high-flow nasal catheters, mask ventilation) can be used to support their breathing. The purpose of this technology is to minimize the impact of general anesthesia, tracheal intubation, mechanical ventilation, etc. on patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Average postoperative hospital stay | up to 3 months | |
| Intraoperative opioid consumption | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Lung collapse score | 1 day | |
| Intraoperative blood gas analysis (Q1h) | 1 day | |
| Conversion to intubation rate |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of nursing education on discharge time and time to first ambulation after surgery | up to 3 months | |
| Comparison of the effects of thoracic paravertebral nerve block and intrathoracic intercostal nerve block | up to 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaolong Yan, Doctor of Medicine (M.D.) | Contact | +8615991269383 | yanxiaolong@fmmu.edu.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15511470 | Background | Pompeo E, Mineo D, Rogliani P, Sabato AF, Mineo TC. Feasibility and results of awake thoracoscopic resection of solitary pulmonary nodules. Ann Thorac Surg. 2004 Nov;78(5):1761-8. doi: 10.1016/j.athoracsur.2004.05.083. | |
| 25489580 | Background | Pompeo E. State of the art and perspectives in non-intubated thoracic surgery. Ann Transl Med. 2014 Nov;2(11):106. doi: 10.3978/j.issn.2305-5839.2014.10.01. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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|
| 1 day |
| Postoperative awakening time | 1 day |
| Time to first ambulation after surgery | up to 3 months |
| Ambulation rate within 4 hours after surgery | up to 3 months |
| Inflammatory markers (IL-6, peripheral neutrophil-to-lymphocyte ratio) | up to 3 months |
| Postoperative drainage volume | up to 3 months |
| Incidence of perioperative complications | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | up to 3 months |
| 15 item Quality of Recovery Rating Scale (QoR-15) | up to 1 year |
| 1-, 3-, and 5-year disease-free survival (DFS) | up to 5 years |
| 1-, 3-, 5-, and 10-year overall survival (OS) | up to 10 years |
| 34765639 | Background | Chiang XH, Lin MW. Converting to Intubation During Non-intubated Thoracic Surgery: Incidence, Indication, Technique, and Prevention. Front Surg. 2021 Oct 26;8:769850. doi: 10.3389/fsurg.2021.769850. eCollection 2021. |
| 26197368 | Background | Lohser J, Slinger P. Lung Injury After One-Lung Ventilation: A Review of the Pathophysiologic Mechanisms Affecting the Ventilated and the Collapsed Lung. Anesth Analg. 2015 Aug;121(2):302-18. doi: 10.1213/ANE.0000000000000808. |
| 30763562 | Background | Hung WT, Hung MH, Wang ML, Cheng YJ, Hsu HH, Chen JS. Nonintubated Thoracoscopic Surgery for Lung Tumor: Seven Years' Experience With 1,025 Patients. Ann Thorac Surg. 2019 Jun;107(6):1607-1612. doi: 10.1016/j.athoracsur.2019.01.013. Epub 2019 Feb 11. |
| 28320572 | Background | Gelzinis TA, Sullivan EA. Non-Intubated General Anesthesia for Video-Assisted Thoracoscopic Surgery. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):407-408. doi: 10.1053/j.jvca.2016.12.027. Epub 2016 Dec 23. No abstract available. |
| 34938770 | Background | Janik M, Juhos P, Lucenic M, Tarabova K. Non-intubated Thoracoscopic Surgery-Pros and Cons. Front Surg. 2021 Dec 6;8:801718. doi: 10.3389/fsurg.2021.801718. eCollection 2021. |
| 26046043 | Background | 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. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |