Comparison Between Spontaneous Breathing-preserving Anesthesia and Double-lumen Endotracheal Intubation Anesthesia in Early-stage Non-small Cell Lung Cancer With a Diameter of ≤ 3 cm: a Prospective, Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 410
- 主要终点
- Average postoperative hospital stay
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 75 years;
- •Gender is not limited;
- •Patients with suspected T1 stage non-small cell lung cancer (NSCLC) in preoperative clinical staging, with thin-slice CT showing that the maximum tumor diameter is ≤ 3.0 cm, single or multiple nodules, and the nodules requiring surgical resection are located in the same ipsilateral lung lobe, with the number of nodules resected simultaneously ≤ 3;
- •American Society of Anesthesiologists (ASA) classification ≤ Grade III (preferably Grade I - II is recommended);
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1;
- •Body Mass Index (BMI) < 25 kg·m-²;
- •Normal cardiopulmonary function: predicted forced expiratory volume in the first second (FEV1%) > 50%, resting blood gas analysis showing arterial oxygen partial pressure (PaO2) ≥ 75 mmHg, arterial carbon dioxide partial pressure (PaCO2) < 45 mmHg; ejection fraction (EF) > 50%, 6-minute walk distance (6MWD) ≥ 350 m;
- •No severe upper airway lesions, Mallampati classification I - II;
- •No contraindications related to paravertebral nerve block and intercostal nerve block;
- •Estimated surgical time ≤ 150 minutes;
- •Patients have no history of clinically significant cardiac or neurological problems.
排除标准
- •A history of ipsilateral lung surgery;
- •Interstitial pneumonia, pulmonary fibrosis, severe emphysema, severe chronic obstructive pulmonary disease, acute phase of pulmonary infection, or uncontrolled asthma;
- •Sleep apnea syndrome with anticipated airway difficulty or difficulty in airway management;
- •Preoperative complications including coagulation dysfunction, hypoxemia, hypercapnia, or hepatic/renal insufficiency;
- •Alteration of anesthesia or surgical plan;
- •Persistent cough or increased risk of high airway secretion reflux;
- •Mental disorders, inability to communicate, or refusal to sign the informed consent form;
- •Participation in other clinical trials within 1 month before this trial;
- •Those who are deemed unfit to participate in this trial by the researchers.
研究组 & 干预措施
group A
Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)
干预措施: Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS) (Procedure)
group B
Tracheal Intubation with One-Lung Ventilation Group (OLV)
干预措施: Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS) (Procedure)
结局指标
主要结局
Average postoperative hospital stay
时间窗: up to 3 months
Intraoperative opioid consumption
时间窗: 1 day
次要结局
- Lung collapse score(1 day)
- Intraoperative blood gas analysis (Q1h)(1 day)
- Conversion to intubation rate(1 day)
- Time to first ambulation after surgery(up to 3 months)
- Postoperative awakening time(1 day)
- 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(up to 3 months)
- 15 item Quality of Recovery Rating Scale (QoR-15)(up to 1 year)