Pulmonary Disease (COPD), Chronic ObstructiveNCT07638176
Effect of Individualized Positive End-expiratory Pressure (PEEP) in Patients Who Have an Intrinsic PEEP During One-lung Ventilation
A study testing PEEP0, PEEP5 and PEEPi in people with Pulmonary Disease (COPD), Chronic Obstructive and Lung Resection Surgery, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Pulmonary Disease (COPD), Chronic Obstructive, Lung Resection Surgery
- What is being tested?
- PEEP0, PEEP5 and PEEPi
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Anesthesiologist, Professor, MD, PhD, +82-2-3410-0784, hyunjooahn@skku.edu
Anesthesiologist, Professor, MD, heejoonjeong@skku.edu
About this study
Official 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
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.
Read the 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.
- Being tested
- PEEP0, PEEP5, PEEPi
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP0Procedure or surgery
PEEP 0 (zero) means off-PEEP on the anesthesia machine.
PEEP5Procedure or surgery
PEEP5 means setting the PEEP to 5 cmH2O on the anesthesia machine.
PEEPiProcedure or surgery
PEEPi (individualized PEEP) means setting the PEEP to 70% of intrinsic PEEP on the anesthesia machine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: PEEP0; Procedure: PEEP5; Procedure: PEEPi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During a 30-minute period from the start of one-lung ventilation to the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Aug 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease (COPD), Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Joo Ahn, Samsung Medical Center
- Investigators
- Hyun Joo Ahn, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638176
- Sponsor's protocol ID
- Individual PEEP trial
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07638176
- Acronym / sponsor ID
- Individual PEEP trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: PEEP0, Procedure: PEEP5, Procedure: PEEPiDuring 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. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Large bullae
- Emergency surgery
- Mechanical ventilation before surgery
- Hemodynamic instability before surgery
- Surgery requiring cardiopulmonary bypass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP0PEEP 0 (zero) means off-PEEP on the anesthesia machine. | Procedure or surgery | Experimental group |
| PEEP5PEEP5 means setting the PEEP to 5 cmH2O on the anesthesia machine. | Procedure or surgery | Experimental group |
| PEEPiPEEPi (individualized PEEP) means setting the PEEP to 70% of intrinsic PEEP on the anesthesia machine. | Procedure or surgery | Experimental group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hyun Joo Ahn, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP0, PEEP5 and PEEPi in people with Pulmonary Disease (COPD), Chronic Obstructive and Lung Resection Surgery, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyun Joo Ahn, MD, PhD (+82234100784, hyunjooahn@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.