Effect of Mechanical Power-based Lung-protective Ventilation During One-lung Ventilation
Incidence of Postoperative Pulmonary Complications Between Mechanical Power-based Versus Conventional Lung Protective Ventilation During One-lung Ventilation: a Randomized Controlled Trial
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Heejoon Jeong Anesthesiologist, Professor, MD
- Phone Number: +82-2-3410-0841
- Email: heejoonjeong@skku.edu
Study Locations
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-
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Seoul, South Korea, 06351
- Samsung Medical Center
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Principal Investigator:
- Heejoon Jeong, MD
-
Contact:
- Heejoon Jeong Anesthesiologist, Professor, MD
- Phone Number: +82-2-3410-0841
- Email: heejoonjeong@skku.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mechanical power-based lung protective ventilation group
Patients in this group will receive the mechanical power-based lung-protective ventilation strategy during one-lung 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
|
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Active Comparator: Conventional ventilation group
Patients in this group will receive the conventional lung-protective ventilation strategy during one-lung ventilation.
|
Ventilator Settings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pulmonary complication
Time Frame: From enrollment to 7 days postoperatively
|
Composite of respiratory diagnoses that share common pathophysiological mechanisms, including pulmonary collapse and airway contamination:
|
From enrollment to 7 days postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clavien-Dindo classification
Time Frame: 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 |
From enrollment to 30 days postoperatively
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- one-lung mechanical power
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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