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NCT Number: NCT07638176

Effect of Individualized Positive End-expiratory Pressure (PEEP) in Patients Who Have an Intrinsic PEEP During One-lung Ventilation

This study investigates the effects of three extrinsic PEEP settings-5 cmH2O, 0 cmH2O, and an individualized PEEP (70% of the measured intrinsic PEEP)-on intrinsic PEEP and hemodynamic stability in patients with intrinsic PEEP undergoing lung resection surgery, using a randomized, crossover design.

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Key information

About this study

Intrinsic positive end-expiratory pressure (iPEEP) frequently occurs during one-lung ventilation (OLV), which is essential for lung resection. This occurrence is driven by three primary factors. First, a significant portion of patients undergoing lung surgery have concomitant chronic obstructive pulmonary disease (COPD) and thus possess a baseline intrinsic PEEP. Second, high-frequency ventilation applied to prevent carbon dioxide accumulation during OLV shortens the expiratory time, thereby generating intrinsic PEEP. Third, the use of a narrow-bore double-lumen endobronchial tube for OLV increases airway resistance, accelerating the development of intrinsic PEEP. Intrinsic PEEP causes lung hyperinflation and elevates intrathoracic pressure, which can subsequently decrease venous return and lead to abrupt hypotension. However, research remains insufficient regarding the optimal level of extrinsic PEEP for patients who develop intrinsic PEEP during OLV. While an extrinsic PEEP of around 5 cmH2O is generally applied during OLV, some guidelines recommend completely removing extrinsic PEEP (0 cmH2O) during OLV in COPD patients. Nevertheless, this recommendation lacks robust scientific evidence. Furthermore, whether the strategy of setting extrinsic PEEP at approximately 70% of intrinsic PEEP-as suggested by studies in critically ill patients-is equally valid in the intraoperative OLV environment remains unverified. Theoretically, if extrinsic PEEP exceeds intrinsic PEEP, it may exacerbate lung hyperinflation by increasing expiratory resistance. Conversely, an extrinsic PEEP that is too low may cause airway collapse during expiration, paradoxically worsening gas trapping. Therefore, this study aims to evaluate the effects of three extrinsic PEEP settings-5 cmH2O, 0 cmH2O, and an individualized PEEP (70% of the measured intrinsic PEEP)-on intrinsic PEEP and hemodynamic stability using a randomized, crossover design.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists Physical Status I - III
  • The Eastern Cooperative Oncology Group Performance Status Grade 0 - 2
  • Lung resection surgery requiring one-lung ventilation for over 60 minutes
  • Indication of double-lumen endobronchial tube (female 35 Fr, male 37 Fr)
  • Patient who is diagnosed with intrinsic PEEP during one-lung ventilation

Exclusion criteria

  • Large bullae
  • Emergency surgery
  • Mechanical ventilation before surgery
  • Hemodynamic instability before surgery
  • Surgery requiring cardiopulmonary bypass
  • Pregnancy, breastfeeding patient
  • Patient's refusal to participate
  • No intrinsic PEEP during one-lung ventilation

Treatment and study plan

PEEP0

Procedure

PEEP 0 (zero) means off-PEEP on the anesthesia machine.

PEEP5

Procedure

PEEP5 means setting the PEEP to 5 cmH2O on the anesthesia machine.

PEEPi

Procedure

PEEPi (individualized PEEP) means setting the PEEP to 70% of intrinsic PEEP on the anesthesia machine.

Primary outcomes

  1. Intrinsic positive end-expiratory airway pressure

    Time frame: During a 30-minute period from the start of one-lung ventilation to the completion of the intervention

    During one-lung ventilation, each patient will randomly receive three PEEP interventions: 0 cmH2O, 5 cmH2O, and the 70% value of intrinsic PEEP. After each 5-minute intervention, intrinsic PEEP will be measured by the anesthesia machine.

  2. Stroke volume

    Time frame: During a 30-minute period from the start of one-lung ventilation to the completion of the intervention

    During one-lung ventilation, each patient will randomly receive three PEEP interventions: 0 cmH2O, 5 cmH2O, and the 70% value of intrinsic PEEP. After each 5-minute intervention, Stroke volume will be measured by an arterial pressure-based cardiac output monitor.

Study contacts

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

Heejoon Jeong, MD

CONTACT

[email protected]

+82234100841

Hyun Joo Ahn, MD, PhD

CONTACT

[email protected]

+82234100784

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Effects of Individualized Positive End-expiratory Pressure (PEEP) on Intrinsic PEEP and Stroke Volume During One-lung Ventilation: a Single-center, Randomized Crossover Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 10, 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.

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