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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07638176
Enrollment
48
Registered
2026-06-10
Start date
2026-08-01
Completion date
2027-05-31
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Resection Surgery, Pulmonary Disease (COPD), Chronic Obstructive

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREPEEP0

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

PROCEDUREPEEP5

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

PROCEDUREPEEPi

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

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

Although all patients will receive three interventions, the order of intervention will be randomly determined. The order of interventions will be blinded to participants, the investigators, and the outcome assessor.

Intervention model description

All participants will receive three types of PEEP interventions during one-lung ventilation. The order of interventions will be determined randomly. Each intervention will last 5 minutes, and a 5-minute washout period will be provided between interventions. At the end of each 5-minute PEEP intervention, primary outcomes (intrinsic PEEP and stroke volume) will be measured.

Eligibility

Sex/Gender
ALL
Age
19 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intrinsic positive end-expiratory airway pressureDuring a 30-minute period from the start of one-lung ventilation to the completion of the interventionDuring 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.
Stroke volumeDuring a 30-minute period from the start of one-lung ventilation to the completion of the interventionDuring 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.

Countries

South Korea

Contacts

CONTACTHyun Joo Ahn, MD, PhD
hyunjooahn@skku.edu+82234100784
CONTACTHeejoon Jeong, MD
heejoonjeong@skku.edu+82234100841
PRINCIPAL_INVESTIGATORHyun Joo Ahn, MD, PhD

Samsung Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026