Effect of Mechanical Power-based Lung-protective Ventilation During One-lung Ventilation

NCT07772804 | Not Yet Recruiting

• 1 other identifier: one-lung mechanical power
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer (Diagnosis); Pulmonary Complications in Surgical Patients

Keywords

mechanical power; lung protective ventilation; postoperative pulmonary complication

Outcome Measures

Primary Outcomes (1)

• Postoperative pulmonary complication

  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).

  From enrollment to 7 days postoperatively

Secondary Outcomes (1)

• Clavien-Dindo classification

  From enrollment to 30 days postoperatively

Study Arms (2)

Mechanical power-based lung protective ventilation group

EXPERIMENTAL

Patients in this group will receive the mechanical power-based lung-protective ventilation strategy during one-lung ventilation.

Procedure: Mechanical power-based lung protective ventilation

Conventional ventilation group

ACTIVE COMPARATOR

Patients in this group will receive the conventional lung-protective ventilation strategy during one-lung ventilation.

Procedure: Conventional lung protective ventilation

Interventions

Mechanical power-based lung protective ventilation PROCEDURE

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.

Mechanical power-based lung protective ventilation group

Conventional lung protective ventilation PROCEDURE

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

Conventional ventilation group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Heejoon Jeong Anesthesiologist, Professor, MD

CONTACT

+82-2-3410-0841; heejoonjeong@skku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Professor

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)