Lung Cancer Requiring Surgical Resection Under One-lung VentilationNCT07044661
Effect of Bilateral vs. Unilateral Alveolar Recruitment on Gas Exchange in Lung Resection
A study testing Unilateral ARM and Bilateral ARM in people with Lung Cancer Requiring Surgical Resection Under One-lung Ventilation, run by Yonsei University at 2 sites in South Korea.
Trial summary
"One-lung ventilation (OLV) is an essential technique during thoracic surgery but preventing atelectasis during OLV remains a key challenge in thoracic anesthesia. Several previous randomized controlled trials have demonstrated that alveolar recruitment maneuvers (ARMs) can significantly reduce driving pressure, peak… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Lung Cancer Requiring Surgical Resection Under One-lung Ventilation
- What is being tested?
- Unilateral ARM and Bilateral ARM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 10 Jul 2025to 10 Jun 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Adult patients aged 20 to 80 years scheduled for thoracoscopic lung resection.
- American Society of Anesthesiologists (ASA) physical status classification of I to III.
Who cannot join
- Anticipated duration of one-lung ventilation (OLV) less than 1 hour.
- Diagnosis of heart failure.
- History of pneumothorax or radiologic evidence of pulmonary blebs or bullae prior to surgery.
- Patients receiving supplemental oxygen therapy or mechanical ventilation prior to surgery.
- Dropout Criteria
- Actual duration of OLV less than 1 hour.
Show all 9Show fewer
- Surgery is canceled or converted to an open thoracotomy or another surgical approach.
- Inability to maintain peripheral oxygen saturation ≥90% despite adjustments in inspired oxygen fraction.
- Inability to maintain ventilator settings due to extensive pulmonary adhesions.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites
Severance Hospital, Yonsei University Health System
Seoul
Severance hospital
Seoul
About this study
"One-lung ventilation (OLV) is an essential technique during thoracic surgery but preventing atelectasis during OLV remains a key challenge in thoracic anesthesia.
Several previous randomized controlled trials have demonstrated that alveolar recruitment maneuvers (ARMs) can significantly reduce driving pressure, peak airway pressure, plateau pressure, and anatomical dead space. However, the optimal method for implementing ARMs has not yet been standardized, as the timing and target of ARM application vary among studies. Some protocols involve applying ARMs to both lungs immediately prior to the initiation of OLV (bilateral ARM), while others apply ARMs solely to the non-operative lung after OLV has begun (unilateral ARM). Bilateral ARM may provide prolonged improvement in gas exchange but carry the risk of insufficient collapse of the operative lung. Conversely, unilateral ARM may facilitate better collapse of the operative lung compared to bilateral ARMs, though potentially at the expense of gas exchange. To date, no study has directly compared these two approaches. This study aims to compare and evaluate the effects of bilateral versus unilateral ARM performed immediately prior to thoracic incision on intraoperative gas exchange and the incidence of intraoperative and postoperative complications."
- Being tested
- Unilateral ARM, Bilateral ARM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral ARMProcedure or surgery
ARM is performed to the dependent lung only. During ARM, mechanical ventilation is set to a pressure-controlled ventilation mode with a driving pressure of 20 cmH₂O and an inspiratory-to-expiratory ratio of 1:1. The positive end-expiratory pressure (PEEP) is increased by 5 cmH₂O every five respiratory cycles, reaching a final PEEP of 20 cmH₂O and a peak airway pressure of 40 cmH₂O, which is then maintained for ten respiratory cycles.
Bilateral ARMProcedure or surgery
ARM is performed to both lungs. During ARM, mechanical ventilation is set to a pressure-controlled ventilation mode with a driving pressure of 20 cmH₂O and an inspiratory-to-expiratory ratio of 1:1. The positive end-expiratory pressure (PEEP) is increased by 5 cmH₂O every five respiratory cycles, reaching a final PEEP of 20 cmH₂O and a peak airway pressure of 40 cmH₂O, which is then maintained for ten respiratory cycles.
| Study group | Role | What they receive |
|---|---|---|
| Uni-ARM group | Active comparator | Unilateral ARM is performed immediately after lateral decubitus positioning of the patient, followed by lung-protective mechanical ventilation with individualized PEEP. Receives: Procedure: Unilateral ARM |
| Bi-ARM group | Experimental | Bilateral ARM is performed immediately after lateral decubitus positioning of the patient, followed by lung-protective mechanical ventilation with individualized PEEP. Receives: Procedure: Bilateral ARM |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO₂/FiO₂ at 60 minutes after ARM
We analyze whether different methods of ARM result in significant differences in the PaO₂/FiO₂ ratio measured at 60 minutes after the initiation of one-lung ventilation (OLV60).
Measured: PaCO₂ is assessed by arterial blood gas analysis at 60 minutes after ARM.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Requiring Surgical Resection Under One-lung VentilationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044661
- Sponsor's protocol ID
- 4-2025-0522
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral vs. Unilateral Alveolar Recruitment on Gas Exchange in Lung Resection
- ClinicalTrials.gov ID
- NCT07044661
- Acronym / sponsor ID
- 4-2025-0522
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 1 Jul 2025 (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.
"One-lung ventilation (OLV) is an essential technique during thoracic surgery but preventing atelectasis during OLV remains a key challenge in thoracic anesthesia.
Several previous randomized controlled trials have demonstrated that alveolar recruitment maneuvers (ARMs) can significantly reduce driving pressure, peak airway pressure, plateau pressure, and anatomical dead space. However, the optimal method for implementing ARMs has not yet been standardized, as the timing and target of ARM application vary among studies. Some protocols involve applying ARMs to both lungs immediately prior to the initiation of OLV (bilateral ARM), while others apply ARMs solely to the non-operative lung after OLV has begun (unilateral ARM). Bilateral ARM may provide prolonged improvement in gas exchange but carry the risk of insufficient collapse of the operative lung. Conversely, unilateral ARM may facilitate better collapse of the operative lung compared to bilateral ARMs, though potentially at the expense of gas exchange. To date, no study has directly compared these two approaches. This study aims to compare and evaluate the effects of bilateral versus unilateral ARM performed immediately prior to thoracic incision on intraoperative gas exchange and the incidence of intraoperative and postoperative complications."
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uni-ARM group | Active comparator | Procedure: Unilateral ARMUnilateral ARM is performed immediately after lateral decubitus positioning of the patient, followed by lung-protective mechanical ventilation with individualized PEEP. |
| Bi-ARM group | Experimental | Procedure: Bilateral ARMBilateral ARM is performed immediately after lateral decubitus positioning of the patient, followed by lung-protective mechanical ventilation with individualized PEEP. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -Adult patients aged 20 to 80 years scheduled for thoracoscopic lung resection.
- American Society of Anesthesiologists (ASA) physical status classification of I to III.
Key exclusion criteria (9 listed)
- Anticipated duration of one-lung ventilation (OLV) less than 1 hour.
- Diagnosis of heart failure.
- History of pneumothorax or radiologic evidence of pulmonary blebs or bullae prior to surgery.
- Patients receiving supplemental oxygen therapy or mechanical ventilation prior to surgery.
- Dropout Criteria
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 |
|---|---|---|
| Unilateral ARMARM is performed to the dependent lung only. During ARM, mechanical ventilation is set to a pressure-controlled ventilation mode with a driving pressure of 20 cmH₂O and an inspiratory-to-expiratory ratio of 1:1. The positive end-expiratory pressure (PEEP) is increased by 5 cmH₂O every five respiratory cycles, reaching a final PEEP of 20 cmH₂O and a peak airway pressure of 40 cmH₂O, which is then maintained for ten respiratory cycles. | Procedure or surgery | Uni-ARM group |
| Bilateral ARMARM is performed to both lungs. During ARM, mechanical ventilation is set to a pressure-controlled ventilation mode with a driving pressure of 20 cmH₂O and an inspiratory-to-expiratory ratio of 1:1. The positive end-expiratory pressure (PEEP) is increased by 5 cmH₂O every five respiratory cycles, reaching a final PEEP of 20 cmH₂O and a peak airway pressure of 40 cmH₂O, which is then maintained for ten respiratory cycles. | Procedure or surgery | Bi-ARM group |
Primary outcome
PaO₂/FiO₂ at 60 minutes after ARM
Time frame: PaCO₂ is assessed by arterial blood gas analysis at 60 minutes after ARM.
We analyze whether different methods of ARM result in significant differences in the PaO₂/FiO₂ ratio measured at 60 minutes after the initiation of one-lung ventilation (OLV60).
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 1 Jul 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral ARM and Bilateral ARM in people with Lung Cancer Requiring Surgical Resection Under One-lung Ventilation, run by Yonsei University at 2 sites 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 2 inclusion and 9 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: opening soon, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO₂/FiO₂ at 60 minutes after ARM (time frame: PaCO₂ is assessed by arterial blood gas analysis at 60 minutes after ARM.). 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 1 Jul 2025.