ClinicalTrials.gg
Not yet recruitingNCT07772804Updated Aug 27, 2026

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

An interventional study of Mechanical power-based lung protective ventilation and Conventional lung protective ventilation in Lung Cancer (Diagnosis) and Pulmonary Complications in Surgical Patients, sponsored by Samsung Medical Center. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Lung Neoplasms by Samsung Medical Center — 5 open to participants now, 6 under way, none of them phase 3. Lung Neoplasms · Samsung Medical Center.

Planned enrollment
4th of 10
164 · median 128
Started
2026
the only one that year
No phase
5 of 22
1 open now
Registered
21st of 22
by date

Among the 22 studies in Lung Neoplasms by Samsung Medical Center, this one is the 4th largest by planned enrollment of the 10 interventional ones, is the only one that started in 2026, is one of 5 with no phase, and was the 21st registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

Observational10 · 2 open
No phasethis study5 · 1 open
Phase 24 · 1 open
Other kind2 · 0 open
Phase 41 · 1 open

By the year they started

First in 2007; this study’s year is marked. 1 started in 2026.

Size and results

Median enrollment 128 across the 10 interventional studies, 390 across the 12 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 22 studies in Lung Neoplasms by Samsung Medical Center, or all of them as a file.
02

Study 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.
03

Conditions studied

  • Lung Cancer (Diagnosis)
  • Pulmonary Complications in Surgical Patients

Keywords

  • mechanical power
  • lung protective ventilation
  • postoperative pulmonary complication
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (ASA) physical status I-III
  • Elective thoracic surgery requiring lung lobectomy under one-lung ventilation
  • Age 18 years or older
  • Written obtained from the patient

Exclusion criteria

Exclusion Criteria

  • Prior history of thoracic surgery
  • Emergency surgery
  • Pregnancy or lactation
  • Known to one-lung ventilation
  • Inability to provide or cooperate with the study protocol
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
164 participants (estimated)

Study arms

  • 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.

    Procedure: Mechanical power-based lung protective ventilation

  • Active comparator
    Conventional ventilation group

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

    Procedure: Conventional lung protective ventilation

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.

  • ProcedureConventional lung protective ventilation

    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

06

What researchers measure

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).

    Time frame: 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

    Time frame: From enrollment to 30 days postoperatively

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07772804
Responsible party
Heejoon Jeong (Anesthesiologist, Professor, Samsung Medical Center) — Principal investigator
First posted
Aug 19, 2026
Start date
Aug 30, 2026 (estimated)
Primary completion
Aug 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Heejoon Jeong Anesthesiologist, Professor, MD
Contact
heejoonjeong@skku.edu
+82-2-3410-0841

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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