Tubeless Anesthesia in Preventing Lung Complications in Patients Undergoing Surgery for Early-Stage Lung Cancer

NCT07024433 | Recruiting DMC

• 1 other identifier: 2024YF068-01
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lung Cancer Patients

Keywords

Early-stage lung cancer; Tubeless anesthesia; Single-port thoracoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  3 days after surgery

Secondary Outcomes (5)

• Intraoperative hemodynamic analysis

  During surgery

• Intraoperative Blood Gas Analysis

  The beginning and once at the end of the surgery.

• Consumption of Anesthetics and Vasoactive Drugs

  During surgery

• Visual Analogue Scale (VAS) for Pain Assessment

  After surgery

• Incidence of Other Adverse Reactions

  Perioperative period

Study Arms (2)

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.

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.

Procedure: Tubeless anesthesia

Interventions

Tubeless anesthesia PROCEDURE

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.

Experimental group (Tubeless anesthesia group)

Traditional tracheal intubation PROCEDURE

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.

Control group (traditional tracheal intubation group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 36737801 BACKGROUND

• 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.

  PMID: 27621880 BACKGROUND

• Kim 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.

  PMID: 37443490 BACKGROUND

• Shao 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.

  PMID: 35840969 BACKGROUND

• Liu 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.

  PMID: 32182334 BACKGROUND

• Yang 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.

  PMID: 37270923 BACKGROUND

• Harris 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.

  PMID: 24093647 BACKGROUND

• Mullan 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.

  PMID: 17380343 BACKGROUND

• Paudel 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.

  PMID: 34597688 BACKGROUND

• Sakuraya 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.

  PMID: 34844655 BACKGROUND

• Ko 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.

  PMID: 31692921 BACKGROUND

• Ichinose 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.

  PMID: 37426169 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Shishi Huang

CONTACT

+81 18120825212; twolions1997@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 17, 2025
• Study Start: May 25, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 3, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)