Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07772804

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Lung Cancer (Diagnosis) Disease Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Complications in Surgical Patients Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Location contact

Heejoon Jeong Anesthesiologist, Professor, MD

CONTACT

[email protected]

+82-2-3410-0841

Heejoon Jeong, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical power-based lung protective ventilation

Procedure

Initial Settings

  • 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
  • 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.
  • 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.
  • If end-tidal carbon dioxide exceeds 50 mmHg, perform arterial blood gas analysis to check arterial pH.
  • 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.

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

Primary outcomes

  1. 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:

    • atelectasis detected on computed tomography or chest radiograph,
    • pneumonia using United States Centers for Disease Control criteria,
    • acute respiratory distress syndrome using the Berlin consensus definition, and
    • pulmonary aspiration (clear clinical history AND radiological evidence).

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Heejoon Jeong Anesthesiologist, Professor, MD

CONTACT

[email protected]

+82-2-3410-0841

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Incidence of Postoperative Pulmonary Complications Between Mechanical Power-based Versus Conventional Lung Protective Ventilation During One-lung Ventilation: a Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.