Mediastinal Mass Requiring Video-assisted Surgical ExcisionNCT06956079
Effect of End-inspiratory Pause on Gas Exchange During Mediastinal Mass Excision With CO2 Insufflation and One-lung Ventilation
A study testing EIP-first and EIP-later in people with Mediastinal Mass Requiring Video-assisted Surgical Excision, run by Yonsei University at 1 site in South Korea.
Trial summary
" Mediastinal mass excision is typically performed via video-assisted thoracoscopic surgery (VATS). To secure a clear surgical field, the ipsilateral lung must be deflated, achieved through one-lung ventilation (OLV) and intrathoracic CO₂ insufflation. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Mediastinal Mass Requiring Video-assisted Surgical Excision
- What is being tested?
- EIP-first and EIP-later
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2025to 10 Mar 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 video-assisted thoracoscopic mediastinal tumor resection.
- American Society of Anesthesiologists (ASA) physical status classification of II (patients with mild systemic disease) or III (patients with severe systemic disease limiting activity).
Who cannot join
- Moderate to severe chronic obstructive pulmonary disease (COPD) according to GOLD criteria: defined as FEV₁/FVC < 0.7 and FEV₁ ≤ 80% of predicted on pulmonary function testing.
- Diffusion capacity of the lung for carbon monoxide (DLCO) < 80% of predicted.
- History of pneumothorax or presence of bullae or blebs on preoperative imaging.
- Inability to read or understand the subject information sheet and consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
" Mediastinal mass excision is typically performed via video-assisted thoracoscopic surgery (VATS). To secure a clear surgical field, the ipsilateral lung must be deflated, achieved through one-lung ventilation (OLV) and intrathoracic CO₂ insufflation. However, OLV increases intrapulmonary shunt due to continued perfusion of the non-ventilated lung, potentially leading to hypoxemia and hypercapnia.
When performed in the supine position, gas exchange becomes more challenging compared to lateral decubitus due to limited gravitational redistribution of blood flow. Although CO₂ insufflation aids surgical exposure through passive lung deflation, it may also increase CVP and PCWP, reduce cardiac output, and raise PaCO₂, contributing to respiratory acidosis.
End-inspiratory pause (EIP), a ventilatory setting that pauses airflow at end-inspiration, prolongs alveolar gas exchange and improves ventilation-perfusion matching. Prior studies show EIP can enhance gas exchange, reduce microatelectasis, and improve CO₂ clearance in patients with acute lung injury. We therefore aimed to assess the effect of EIP application during VATS mediastinal mass excicion.
- Being tested
- EIP-first, EIP-later
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIP-firstProcedure or surgery
EIP is applied for 20 minutes immediately after the initiation of one-lung ventilation, followed by conventional mechanical ventilation.
EIP-laterProcedure or surgery
Conventional mechanical ventilation is applied for 20 minutes after the initiation of one-lung ventilation, followed by EIP application.
| Study group | Role | What they receive |
|---|---|---|
| EIP-first group | Experimental | EIP is applied for 20 minutes immediately after the initiation of one-lung ventilation, followed by conventional mechanical ventilation. Receives: Procedure: EIP-first |
| EIP-later group | Active comparator | Conventional mechanical ventilation is applied for 20 minutes after the initiation of one-lung ventilation, followed by EIP application. Receives: Procedure: EIP-later |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaCO₂ at 20 minutes after each ventilation method
The study aimed to evaluate whether the application of EIP resulted in a significant intergroup difference in PaCO₂.
Measured: PaCO₂ is assessed at 20 minutes after each ventilation method
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study startMay 2025 (estimated)
- Primary completion10 Mar 2027 (estimated)
- Study completion10 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal Mass Requiring Video-assisted Surgical ExcisionStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 58 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
- NCT06956079
- Sponsor's protocol ID
- 4-2025-0232
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 2 May 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of End-inspiratory Pause on Gas Exchange During Mediastinal Mass Excision With CO2 Insufflation and One-lung Ventilation
- ClinicalTrials.gov ID
- NCT06956079
- Acronym / sponsor ID
- 4-2025-0232
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 10 Mar 2027 (estimated)
- First posted
- 2 May 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.
" Mediastinal mass excision is typically performed via video-assisted thoracoscopic surgery (VATS). To secure a clear surgical field, the ipsilateral lung must be deflated, achieved through one-lung ventilation (OLV) and intrathoracic CO₂ insufflation. However, OLV increases intrapulmonary shunt due to continued perfusion of the non-ventilated lung, potentially leading to hypoxemia and hypercapnia.
When performed in the supine position, gas exchange becomes more challenging compared to lateral decubitus due to limited gravitational redistribution of blood flow. Although CO₂ insufflation aids surgical exposure through passive lung deflation, it may also increase CVP and PCWP, reduce cardiac output, and raise PaCO₂, contributing to respiratory acidosis.
End-inspiratory pause (EIP), a ventilatory setting that pauses airflow at end-inspiration, prolongs alveolar gas exchange and improves ventilation-perfusion matching. Prior studies show EIP can enhance gas exchange, reduce microatelectasis, and improve CO₂ clearance in patients with acute lung injury. We therefore aimed to assess the effect of EIP application during VATS mediastinal mass excicion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIP-first group | Experimental | Procedure: EIP-firstEIP is applied for 20 minutes immediately after the initiation of one-lung ventilation, followed by conventional mechanical ventilation. |
| EIP-later group | Active comparator | Procedure: EIP-laterConventional mechanical ventilation is applied for 20 minutes after the initiation of one-lung ventilation, followed by EIP application. |
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 video-assisted thoracoscopic mediastinal tumor resection.
- American Society of Anesthesiologists (ASA) physical status classification of II (patients with mild systemic disease) or III (patients with severe systemic disease limiting activity).
Key exclusion criteria (4 listed)
- Moderate to severe chronic obstructive pulmonary disease (COPD) according to GOLD criteria: defined as FEV₁/FVC < 0.7 and FEV₁ ≤ 80% of predicted on pulmonary function testing.
- Diffusion capacity of the lung for carbon monoxide (DLCO) < 80% of predicted.
- History of pneumothorax or presence of bullae or blebs on preoperative imaging.
- Inability to read or understand the subject information sheet and consent form.
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 |
|---|---|---|
| EIP-firstEIP is applied for 20 minutes immediately after the initiation of one-lung ventilation, followed by conventional mechanical ventilation. | Procedure or surgery | EIP-first group |
| EIP-laterConventional mechanical ventilation is applied for 20 minutes after the initiation of one-lung ventilation, followed by EIP application. | Procedure or surgery | EIP-later group |
Primary outcome
PaCO₂ at 20 minutes after each ventilation method
Time frame: PaCO₂ is assessed at 20 minutes after each ventilation method
The study aimed to evaluate whether the application of EIP resulted in a significant intergroup difference in PaCO₂.
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 2 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIP-first and EIP-later in people with Mediastinal Mass Requiring Video-assisted Surgical Excision, run by Yonsei University 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 2 inclusion and 4 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 2 May 2025. 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?
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?
PaCO₂ at 20 minutes after each ventilation method (time frame: PaCO₂ is assessed at 20 minutes after each ventilation method). 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 2 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.