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

NCT07638176 | Not Yet Recruiting

• 1 other identifier: Individual PEEP trial
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Intrinsic positive end-expiratory airway pressure

  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.

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

• Stroke volume

  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.

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

Study Arms (1)

Experimental group

EXPERIMENTAL

During one-lung ventilation, baseline intrinsic PEEP and stroke volume will be measured. All participants will receive three PEEP interventions: 0 cmH2O, 5 cmH2O, and 70% of the intrinsic PEEP value. The order of interventions is randomized. Each intervention will be maintained for 5 minutes, with a 5-minute washout period between interventions to minimize mutual interference. At the end of each intervention, two primary outcomes (intrinsic PEEP and stroke volume) will be measured.

Procedure: PEEP0; Procedure: PEEP5; Procedure: PEEPi

Interventions

PEEP0 PROCEDURE

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

Experimental group

PEEP5 PROCEDURE

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

Experimental group

PEEPi PROCEDURE

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

Experimental group

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hyun Joo Ahn, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Joo Ahn, MD, PhD

CONTACT

+82234100784; hyunjooahn@skku.edu

Heejoon Jeong, MD

CONTACT

+82234100841; heejoonjeong@skku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06