Reducing Pneumonia with LMA in Lung Wedge Resection

March 7, 2025 updated by: Hai Feng

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

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)).

Study Overview

Detailed Description

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)).

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hai Feng, Master
  • Phone Number: +8615550435795
  • Email: 23014881@qq.com

Study Locations

    • Shandong
      • Jinan, Shandong, China, 250000
        • Shandong First Medical University, First Affiliated Hospital (Qianfo Mountain Hospital of Shandong Province)
        • Contact:
          • Bo Jian Wu, Docter
          • Phone Number: +8618560083793

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult patients undergoing thoracoscopic wedge resection of the lung under general anesthesia

Description

Inclusion Criteria:

  1. Age ≥ 18 years ;
  2. Patients undergoing thoracoscopic pulmonary wedge resection ;
  3. General anesthesia administered intraoperatively (LMA-SBA or endotracheal intubation);
  4. 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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Spontaneous Breathing LMA Group
Patients in this group received general anesthesia using a laryngeal mask airway (LMA) while maintaining spontaneous breathing throughout the procedure. No muscle relaxants were used, and a vagus nerve block was performed to prevent coughing reflexes. Urinary catheters and chest drainage tubes were generally not placed.
Single-Lung Ventilation Group
Patients in this group received general anesthesia with single-lung isolation and mechanical ventilation. Airway management included double-lumen tubes, single-lumen tubes with bronchial blockers, or LMAs with bronchial blockers. Muscle relaxants were used, and ventilation was controlled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Within 30 days post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after surgery
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.
First 3 days post-surgery
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.
Within 24 hours post-surgery
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.
Within 24 hours post-surgery
length of hospital stay after surgery
Time Frame: From surgery to discharge, up to 30 days
Total number of days from surgery to discharge.
From surgery to discharge, up to 30 days
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.
Within 72 hours post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2025

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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