Lung Cancer (Diagnosis), Pulmonary Complications in Surgical Patients
Conditions
Keywords
mechanical power, lung protective ventilation, postoperative pulmonary complication
Brief summary
The goal of this clinical trial is to determine whether a mechanical power-based lung-protective ventilation strategy during one-lung ventilation reduces the incidence of postoperative pulmonary complications in adult patients undergoing lung resection surgery. Mechanical power during pressure-regulated volume control mode is calculated using the formula below. Mechanical power (J/min) = 0.098 x respiratory rate x tidal volume x (inspiratory airway pressure above positive end-expiratory pressure + positive end-expiratory pressure) The main questions it aims to answer are: * Does a mechanical power-based lung-protective ventilation strategy significantly lower the incidence of major postoperative pulmonary complications compared to conventional ventilation? * How does this strategy impact intraoperative hemodynamic and vital profiles (e.g., blood pressure, cardiac output, vasopressor requirements, and blood oxygen saturation) during one-lung ventilation? Participants will: * Be randomized to receive either a mechanical power-based lung-protective ventilation strategy or a conventional lung-protective ventilation strategy exclusively during one-lung ventilation. * Be closely monitored for the occurrence of major postoperative pulmonary complications (atelectasis, pneumonia, acute respiratory distress syndrome, and pulmonary aspiration) and adverse events for 1 month postoperatively.
Interventions
PROCEDUREMechanical power-based lung protective ventilation
Initial Settings 1\) Tidal Volume: 4-6 mL/kg of predicted body weight 2) Positive End-Expiratory Pressure: Set to the value that minimizes driving pressure 3) Respiratory Rate: Adjusted to maintain an end-tidal carbon dioxide of 35-45 mmHg Protocol 1. If mechanical power exceeds 7 J/min, decrease the respiratory rate by 1 and reduce the tidal volume by 5%, then maintain these settings for 1 minute. 2. If mechanical power remains above 7 J/min after 1 minute, further decrease the respiratory rate by 1 and reduce the tidal volume by an additional 5%, then maintain for 1 minute. 3. If end-tidal carbon dioxide exceeds 50 mmHg, perform arterial blood gas analysis to check arterial pH. 4. If arterial pH drops below 7.2, the intervention will be discontinued, and the patient will be withdrawn from the study and treated with conventional treatment.
Ventilator Settings * Tidal Volume: 4-6 mL/kg of predicted body weight * Positive End-Expiratory Pressure: 5 cmH2O * Respiratory Rate: Adjusted to maintain an end-tidal carbon dioxide of 35-45 mmHg
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status I-III * Elective thoracic surgery requiring lung lobectomy under one-lung ventilation * Age 18 years or older * Written informed consent obtained from the patient
Exclusion criteria
* Prior history of thoracic surgery * Emergency surgery * Pregnancy or lactation * Known contraindication to one-lung ventilation * Inability to provide informed consent or cooperate with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pulmonary complication | From enrollment to 7 days postoperatively | Composite of respiratory diagnoses that share common pathophysiological mechanisms, including pulmonary collapse and airway contamination: 1. atelectasis detected on computed tomography or chest radiograph, 2. pneumonia using United States Centers for Disease Control criteria, 3. acute respiratory distress syndrome using the Berlin consensus definition, and 4. pulmonary aspiration (clear clinical history AND radiological evidence). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clavien-Dindo classification | From enrollment to 30 days postoperatively | The Clavien-Dindo classification is a standardized grading system for postoperative complications based on the therapeutic treatment required to manage the complication. The Clavien-Dindo classification grades surgical complications according to the invasiveness and complexity of the therapy needed to treat them, ranging from any deviation from the normal postoperative course to death. Grading Scale Overview Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment. Grade II: Requiring pharmacological treatment with drugs other than those allowed for Grade I complications Grade III: Requiring surgical, endoscopic, or radiological intervention. Grade IV: Life-threatening complication. Grade V: Death of a patient |
Countries
South Korea
Contacts
CONTACTHeejoon Jeong Anesthesiologist, Professor, MD
Outcome results
None listed