Pneumonia, PostoperativeNCT06873958
Reducing Pneumonia with LMA in Lung Wedge Resection
An observational study of Pneumonia, Postoperative and Anesthesia, run by Hai Feng at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Postoperative, Anesthesia, Thoracic Surgery
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2025to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients undergoing thoracoscopic wedge resection of the lung under general anesthesia
Who may be able to join
- Age ≥ 18 years ;
- Patients undergoing thoracoscopic pulmonary wedge resection ;
- General anesthesia administered intraoperatively (LMA-SBA or endotracheal intubation);
- Complete preoperative and postoperative clinical data.
Who cannot join
- -
- 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 .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shandong First Medical University, First Affiliated Hospital (Qianfo Mountain Hospital of Shandong Province)
Jinan, Shandong, 250000
Bo Jian Wu, Docter, +8618560083793
About this study
Official title: 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)).
Read the 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)).
- Keywords
- Laryngeal Mask Anesthesia, Spontaneous Breathing, Single-Lung Ventilation, Postoperative Pneumonia, Thoracoscopic Wedge Resection, Propensity Score, Retrospective Cohort Study
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Pneumonia
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.
Measured: Within 30 days post-surgery
Secondary outcomes (6)
Postoperative Recovery Time
Time from the end of anesthesia to the patient's full recovery of consciousness, measured in minutes.
Measured: Immediately after surgery
Area Under the Fever Curve Over 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.
Measured: First 3 days post-surgery
White Blood Cell Count at 24 Hours Post-Surgery
White blood cell count measured in peripheral blood within 24 hours after surgery, reported in cells/μL.
Measured: Within 24 hours post-surgery
Neutrophil Percentage at 24 Hours Post-Surgery
Percentage of neutrophils in peripheral blood within 24 hours after surgery.
Measured: Within 24 hours post-surgery
length of hospital stay after surgery
Total number of days from surgery to discharge.
Measured: From surgery to discharge, up to 30 days
ICU Admission Rate Within 72 Hours Post-Surgery
Proportion of patients admitted to the intensive care unit (ICU) within 72 hours after surgery due to any cause.
Measured: Within 72 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hai Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hai Feng, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873958
- Sponsor's protocol ID
- YXLL-KY-2025(037)
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Postoperative Pneumonia Risk with Spontaneous Breathing Laryngeal Mask Anesthesia in Thoracoscopic Wedge Resection: a Propensity Score Overlap-Weighted Multifactorial Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06873958
- Acronym / sponsor ID
- YXLL-KY-2025(037)
- Keywords
- Laryngeal Mask Anesthesia, Spontaneous Breathing, Single-Lung Ventilation, Postoperative Pneumonia, Thoracoscopic Wedge Resection, Propensity Score, Retrospective Cohort Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Hai FengUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients undergoing thoracoscopic wedge resection of the lung under general anesthesia
Key inclusion criteria (4 listed)
- Age ≥ 18 years ;
- Patients undergoing thoracoscopic pulmonary wedge resection ;
- General anesthesia administered intraoperatively (LMA-SBA or endotracheal intubation);
- Complete preoperative and postoperative clinical data.
Key exclusion criteria (2 listed)
- -
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Postoperative Recovery Time
Time frame: Immediately after surgery
Area Under the Fever Curve Over 3 Days Post-Surgery
Time frame: First 3 days post-surgery
White Blood Cell Count at 24 Hours Post-Surgery
Time frame: Within 24 hours post-surgery
Neutrophil Percentage at 24 Hours Post-Surgery
Time frame: Within 24 hours post-surgery
length of hospital stay after surgery
Time frame: From surgery to discharge, up to 30 days
ICU Admission Rate Within 72 Hours Post-Surgery
Time frame: Within 72 hours post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Related trials for Pneumonia, Postoperative
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Not yet recruiting
BIS in ICU Interventional Study
Cardiac Surgical Procedures (Postoperative Population), Critical Illness
Recruiting
Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning.
Acute Respiratory Distress Syndrome (ARDS), Pneumonia
Not yet recruiting
Effect of Positioning and ACBT on Pulmonary Complications After Cardiac Surgery
Postoperative Pulmonary Complications (PPCs), Cardiac Surgery With Sternotomy
Not yet recruiting
High-Flow Nasal Cannula After Major Abdominal Surgery to Prevent Postoperative Pulmonary Complications
Postoperative Complications, Atelectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Postoperative and Anesthesia, run by Hai Feng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hai Feng, Master (+8615550435795, 23014881@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Pneumonia (time frame: Within 30 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.