跳至主要内容
临床试验/NCT06873958
NCT06873958尚未招募不适用

Reducing Postoperative Pneumonia Risk with Spontaneous Breathing Laryngeal Mask Anesthesia in Thoracoscopic Wedge Resection: a Propensity Score Overlap-Weighted Multifactorial Retrospective Cohort Study

Hai Feng1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2025年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
700
试验地点
1
主要终点
Incidence of Postoperative Pneumonia

研究概览

简要总结

This retrospective cohort study aims to evaluate whether spontaneous breathing laryngeal mask anesthesia (LMA-SBA) reduces the incidence of postoperative pneumonia compared to single-lung isolation mechanical ventilation in patients undergoing thoracoscopic wedge resection. Using propensity score overlap weighting, we will adjust for multiple confounders, including age, COPD, surgical duration, and preoperative laboratory values. Secondary outcomes include postoperative recovery time, fever severity, white blood cell count, neutrophil percentage, length of hospital stay, and ICU admission rate. The study has been approved by the Ethics Committee of the First Affiliated Hospital of Shandong First Medical University (Approval No. YXLL-KY-2025(037)).

详细描述

Background: Postoperative pneumonia is a significant complication following thoracoscopic wedge resection, potentially linked to the type of anesthesia used. Spontaneous breathing laryngeal mask anesthesia (LMA-SBA) may offer advantages over traditional single-lung isolation mechanical ventilation by preserving natural respiratory function and reducing mechanical ventilation-related lung injury.

Objective

The primary objective is to compare the incidence of postoperative pneumonia between LMA-SBA and single-lung isolation mechanical ventilation groups. Secondary objectives include assessing differences in postoperative recovery time, fever severity, white blood cell count, neutrophil percentage, length of hospital stay, and ICU admission rate.

Methods: This retrospective cohort study will include patients aged ≥18 years who underwent thoracoscopic wedge resection under general anesthesia (LMA-SBA or single-lung isolation mechanical ventilation) at the First Affiliated Hospital of Shandong First Medical University between March 1, 2024, and November 31, 2024. Exclusion criteria include prior thoracic surgery, pleural adhesions, conversion to single-lung isolation during surgery, severe cardiopulmonary dysfunction, and inability to cooperate with postoperative assessments. Data will be collected from electronic medical records, and propensity score overlap weighting will be used to adjust for confounders.

Outcome Measures: Postoperative pneumonia will be diagnosed based on fever (>38°C), cough, new infiltrates on imaging, and abnormal white blood cell count (>10,000/μL or <4,000/μL). Secondary outcomes will be analyzed using weighted regression models.

Ethics: The study protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Shandong First Medical University (Approval No. YXLL-KY-2025(037)).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years ;
  • Patients undergoing thoracoscopic pulmonary wedge resection ;
  • General anesthesia administered intraoperatively (LMA-SBA or endotracheal intubation);
  • Complete preoperative and postoperative clinical data.

排除标准

  • History of prior thoracic surgery; 2)Pleural adhesion or pleural effusion caused by tuberculosis or other diseases; 3)Intraoperative conversion from tubeless anesthesia to single-lung isolation-controlled ventilation; 4)Severe cardiopulmonary dysfunction (e.g., history of acute exacerbation of COPD within 1 month preoperatively, patients requiring emergency treatment, or cardiac insufficiency with limited mobility) ; 5)Preoperative neurological dysfunction or sensory abnormalities affecting pain assessment 6)Inability to cooperate with postoperative pain assessment and follow-up 7)Pregnant or breastfeeding women; 8)Patients transferred from other departments with complex comorbidities, prior treatment history, or unstable conditions .

结局指标

主要结局

Incidence of Postoperative Pneumonia

时间窗: Within 30 days post-surgery

Postoperative pneumonia is defined based on the American Thoracic Society (ATS) and Infectious Diseases Society of America (IDSA) guidelines, including: Fever (body temperature \>38°C); Cough, sputum production, or dyspnea; New or progressive infiltrates on chest imaging; Leukocytosis (\>10,000/μL) or leukopenia (\<4,000/μL). The incidence will be calculated as the proportion of patients diagnosed with pneumonia within 30 days post-surgery.

次要结局

  • Postoperative Recovery Time(Immediately after surgery)
  • Area Under the Fever Curve Over 3 Days Post-Surgery(First 3 days post-surgery)
  • Neutrophil Percentage at 24 Hours Post-Surgery(Within 24 hours post-surgery)
  • White Blood Cell Count at 24 Hours Post-Surgery(Within 24 hours post-surgery)
  • length of hospital stay after surgery(From surgery to discharge, up to 30 days)
  • ICU Admission Rate Within 72 Hours Post-Surgery(Within 72 hours post-surgery)

研究者

发起方
Hai Feng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hai Feng

professor

Qianfoshan Hospital

研究点 (1)

Loading locations...

相似试验