Clinical trial NCT07024433: Tubeless Anesthesia in Preventing Lung Complications in Patients Undergoing Surgery for Early-Stage Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer Patients
Keywords: Early-stage lung cancer
Tubeless anesthesia
Single-port thoracoscopic surgery
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and ≤70 years;
2. ECOG performance status score 0-1;
3. Good cardiac and pulmonary function;
4. Single or multiple peripheral lung nodules planned for single-port thoracoscopic surgery, with or without mediastinal lymph node dissection or sampling;
5. Able to comply with the study visit schedule and other protocol requirements;
6. Signed informed consent and voluntary participation in the study.

Exclusion Criteria:

1. Obese patients (BMI \>30);
2. Patients with difficult intubation or expected complex airway management;
3. COPD patients with copious airway secretions;
4. Patients with neurological dysfunction or who cannot cooperate while awake;
5. Patients expected to have extensive pleural adhesions or with previous lung resection;
6. Elderly and frail patients with severe hypoxia (PaO2 \<60 mmHg) or hypercapnia (PaCO2 \>50/55 mmHg);
7. Previous induction chemotherapy or chemoradiotherapy;
8. Intraoperative need to isolate the lung to prevent spillage and contamination of the contralateral lung;
9. Patients expected to have large surgical wounds and lengthy procedures, clinically assessed as unsuitable;
10. Patients whose cardiac and pulmonary function, or overall health, cannot withstand the procedure.

Primary outcomes:
measure: Contralateral lung complications
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Intraoperative hemodynamic analysis
timeFrame: During surgery
measure: Intraoperative Blood Gas Analysis
timeFrame: The beginning and once at the end of the surgery.
measure: Consumption of Anesthetics and Vasoactive Drugs
timeFrame: During surgery
measure: Visual Analogue Scale (VAS) for Pain Assessment
timeFrame: After surgery
measure: Incidence of Other Adverse Reactions
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
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