Lung Cancer (Diagnosis)NCT07772804
Effect of Mechanical Power-based Lung-protective Ventilation During One-lung Ventilation
A study testing Mechanical power-based lung protective ventilation and Conventional lung protective ventilation in people with Lung Cancer (Diagnosis) and Pulmonary Complications in Surgical Patients, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis), Pulmonary Complications in Surgical Patients
- What is being tested?
- Mechanical power-based lung protective ventilation and Conventional lung protective ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2026to 30 Sep 2027
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samsung Medical Center
Seoul, 06351
Heejoon Jeong Anesthesiologist, Professor, MD, +82-2-3410-0841, heejoonjeong@skku.edu
Heejoon Jeong, MD
About this study
Official title: 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.
Read more
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.
- Being tested
- Mechanical power-based lung protective ventilation, Conventional lung protective ventilation
- Keywords
- mechanical power, lung protective ventilation, postoperative pulmonary complication
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical power-based lung protective ventilationProcedure or surgery
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 ventilationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional lung protective ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complication
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).
Measured: From enrollment to 7 days postoperatively
Secondary outcomes (1)
Clavien-Dindo classification
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
Measured: From enrollment to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heejoon Jeong, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772804
- Sponsor's protocol ID
- one-lung mechanical power
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Pulmonary Complications Between Mechanical Power-based Versus Conventional Lung Protective Ventilation During One-lung Ventilation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07772804
- Acronym / sponsor ID
- one-lung mechanical power
- Keywords
- mechanical power, lung protective ventilation, postoperative pulmonary complication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Aug 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical power-based lung protective ventilation group | Experimental | Procedure: Mechanical power-based lung protective ventilationPatients in this group will receive the mechanical power-based lung-protective ventilation strategy during one-lung ventilation. |
| Conventional ventilation group | Active comparator | Procedure: Conventional lung protective ventilationPatients in this group will receive the conventional lung-protective ventilation strategy during one-lung ventilation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical power-based lung protective ventilationInitial 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. | Procedure or surgery | Mechanical power-based lung protective ventilation group |
| Conventional lung protective ventilationVentilator 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 | Procedure or surgery | Conventional ventilation group |
Primary outcome
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: 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).
1 secondary outcome
Clavien-Dindo classification
Time frame: From enrollment to 30 days postoperatively
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 27 Aug 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Mechanical power-based lung protective ventilation and Conventional lung protective ventilation in people with Lung Cancer (Diagnosis) and Pulmonary Complications in Surgical Patients, run by Samsung Medical Center at 1 site in South Korea.
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 5 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 27 Aug 2026. 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 South Korea. 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 Heejoon Jeong Anesthesiologist, Professor, MD (+82-2-3410-0841, heejoonjeong@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complication (time frame: From enrollment to 7 days postoperatively). 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 27 Aug 2026.