- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06873958
Reducing Pneumonia with LMA in Lung Wedge Resection
Reducing Postoperative Pneumonia Risk with Spontaneous Breathing Laryngeal Mask Anesthesia in Thoracoscopic Wedge Resection: a Propensity Score Overlap-Weighted Multifactorial Retrospective Cohort Study
Study Overview
Status
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hai Feng, Master
- Phone Number: +8615550435795
- Email: 23014881@qq.com
Study Locations
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Shandong
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Jinan, Shandong, China, 250000
- Shandong First Medical University, First Affiliated Hospital (Qianfo Mountain Hospital of Shandong Province)
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Contact:
- Bo Jian Wu, Docter
- Phone Number: +8618560083793
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
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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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of Postoperative Pneumonia
Time Frame: Within 30 days post-surgery
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Recovery Time
Time Frame: Immediately after surgery
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Time from the end of anesthesia to the patient's full recovery of consciousness, measured in minutes.
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Immediately after surgery
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Area Under the Fever Curve Over 3 Days Post-Surgery
Time Frame: First 3 days post-surgery
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The area under the curve (AUC) of body temperature over the first 3 days post-surgery, calculated from temperature measurements taken every 6 hours.
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First 3 days post-surgery
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White Blood Cell Count at 24 Hours Post-Surgery
Time Frame: Within 24 hours post-surgery
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White blood cell count measured in peripheral blood within 24 hours after surgery, reported in cells/μL.
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Within 24 hours post-surgery
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Neutrophil Percentage at 24 Hours Post-Surgery
Time Frame: Within 24 hours post-surgery
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Percentage of neutrophils in peripheral blood within 24 hours after surgery.
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Within 24 hours post-surgery
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length of hospital stay after surgery
Time Frame: From surgery to discharge, up to 30 days
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Total number of days from surgery to discharge.
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From surgery to discharge, up to 30 days
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ICU Admission Rate Within 72 Hours Post-Surgery
Time Frame: Within 72 hours post-surgery
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Proportion of patients admitted to the intensive care unit (ICU) within 72 hours after surgery due to any cause.
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Within 72 hours post-surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YXLL-KY-2025(037)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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