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NCT Number: NCT06873958

Reducing Pneumonia with LMA in Lung Wedge Resection

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)).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shandong First Medical University, First Affiliated Hospital (Qianfo Mountain Hospital of Shandong Province)

Jinan, Shandong, 250000, China

Location contact

Bo Jian Wu, Docter

CONTACT

+8618560083793

About this study

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)).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

1)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 .

Treatment and study plan

Primary outcomes

  1. Incidence of Postoperative Pneumonia

    Time frame: 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.

Secondary outcomes

  1. Postoperative Recovery Time

    Time frame: Immediately after surgery

    Time from the end of anesthesia to the patient's full recovery of consciousness, measured in minutes.

  2. Area Under the Fever Curve Over 3 Days Post-Surgery

    Time frame: First 3 days post-surgery

    The area under the curve (AUC) of body temperature over the first 3 days post-surgery, calculated from temperature measurements taken every 6 hours.

  3. White Blood Cell Count at 24 Hours Post-Surgery

    Time frame: Within 24 hours post-surgery

    White blood cell count measured in peripheral blood within 24 hours after surgery, reported in cells/μL.

  4. Neutrophil Percentage at 24 Hours Post-Surgery

    Time frame: Within 24 hours post-surgery

    Percentage of neutrophils in peripheral blood within 24 hours after surgery.

  5. length of hospital stay after surgery

    Time frame: From surgery to discharge, up to 30 days

    Total number of days from surgery to discharge.

  6. ICU Admission Rate Within 72 Hours Post-Surgery

    Time frame: Within 72 hours post-surgery

    Proportion of patients admitted to the intensive care unit (ICU) within 72 hours after surgery due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Hai Feng, Master

CONTACT

[email protected]

+8615550435795

Sponsors and collaborators

Lead sponsor

Hai Feng

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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