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

25. august 2026 opdateret af: Heejoon Jeong, Samsung Medical Center

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

164

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Heejoon Jeong Anesthesiologist, Professor, MD
  • Telefonnummer: +82-2-3410-0841
  • E-mail: heejoonjeong@skku.edu

Studiesteder

  • Sydkorea
      • Seoul, Sydkorea, 06351
        • Samsung Medical Center
        • Ledende efterforsker:
          • Heejoon Jeong, MD
        • Kontakt:
          • Heejoon Jeong Anesthesiologist, Professor, MD
          • Telefonnummer: +82-2-3410-0841
          • E-mail: heejoonjeong@skku.edu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

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.
Aktiv komparator: Conventional ventilation group
Patients in this group will receive the conventional lung-protective ventilation strategy during one-lung ventilation.
Procedure: Conventional 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative pulmonary complication
Tidsramme: 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).
From enrollment to 7 days postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clavien-Dindo classification
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samsung Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. august 2026

Primær færdiggørelse (Anslået)

30. august 2027

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

14. august 2026

Først indsendt, der opfyldte QC-kriterier

14. august 2026

Først opslået (Faktiske)

19. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • one-lung mechanical power

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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