Patients Who Underwent CPB for MICSNCT04985513
EIT Based Regional Lung Ventilation in Minimally Invasive Cardiac Surgery
A study testing Ventilation during cardiopulmonary bypass in people with Patients Who Underwent CPB for MICS, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
Electrical impedance tomography (EIT) is a non-invasive, radiation-free imaging technique that measures local pulmonary ventilation and ventilation distribution through potential changes on the skin surface of the chest wall during the respiratory cycle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Who Underwent CPB for MICS
- What is being tested?
- Ventilation during cardiopulmonary bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Aug 2021to 9 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years of age
- Patients who underwent one lung ventilation using a bronchial blocker for minimally invasive cardiac surgery
- If there is no atelectasis on chest X-ray or chest computed tomography performed before surgery
Who cannot join
- If there is evidence of atelectasis, pneumonia, or lung disease that can reduce lung volume in a chest X-ray examination or chest computed tomography performed before surgery
- Patients scheduled for sternotomy
- If there is a skin disease in the chest that requires EIT measurement
- If there is a plan to transfer to the intensive care unit while maintaining the endotracheal tube
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Impedance Tomography Based Regional Lung Ventilation Evaluation According to Ventilation Strategy During Cardiopulmonary Bypass in Minimally Invasive Cardiac Surgery
Electrical impedance tomography (EIT) is a non-invasive, radiation-free imaging technique that measures local pulmonary ventilation and ventilation distribution through potential changes on the skin surface of the chest wall during the respiratory cycle. Recently, a global inhomogeneity (GI) index has been proposed and used to quantify the distribution of tidal volume in the lungs. Currently, there are research results showing that ventilation improves postoperative oxygenation and gas exchange when ventilation is applied during CPB, but the evidence for long-term prognosis is lacking. In this study, researchers performed electrical impedance tomography in the intensive care unit immediately after surgery on patients who had undergone endotracheal tube extubation in the operating room immediately after completing minimally invasive cardiac surgery by collapsing the right lung through right minimal thoracotomy. The purpose of this study is to measure local pulmonary ventilation and ventilation distribution using this method and to find the optimal left lung ventilation method during minimally invasive cardiac surgery based on this. Identifying the difference in postoperative pulmonary ventilation disorders and functional regional ventilation according to the pulmonary ventilation strategy at the time of CPB in minimally invasive cardiac surgery can help predict the risk of pulmonary complications and improve the prognosis of patients after surgery.
Read the detailed description
Minimally invasive cardiac surgery (MICS) is a safe and effective surgical method that reduces bleeding, number of reoperations, postoperative pain, and length of stay in the ICU, and promotes faster recovery compared to conventional open thoracic cardiac surgery. In general, since cardiopulmonary bypass (CPB) is used during minimally invasive cardiac surgery using right thoracotomy, both lungs can be maintained in a lung rest state. Except for 2-3 ventilations when releasing the aortic forceps during surgery, there is no ventilation at all during CPB, and both lung ventilation starts when CPB is stopped. In order to secure the surgical field of view during surgery, most anesthetists do not ventilate the right lung and maintain a collapsed state. Even during CPB, ventilation can be performed without affecting the field of vision at the surgical site. However, to date, it is not well known about the proper ventilation method for the left lung during cardiac surgery using CPB.
Pulmonary complications are major postoperative complications of minimally invasive cardiac surgery and are factors that increase postoperative pulmonary complications, such as age, preoperative lung disease, and duration of CPB, which are well-known. Failure to ventilate the entire lung field at the time of CPB may cause atelectrauma, and even if normal ventilation is performed after CPB, and shearing force from repeated collapse and expansion of the atelectasis area may occur. In addition, such atelectasis can lead to not only ventilation disorders, ventilation/perfusion imbalances, but also postoperative pneumonia and poor prognosis. In particular, since right thoracotomy is mainly performed in minimally invasive cardiac surgery, the right lung collapses through one lung ventilation from the start of the operation to the access to the surgical site or at the end of the operation to check for bleeding at the surgical site. Therefore, one lung ventilation may be required even after weaning from the CPB, which may increase the risk of atelectasis in the operated side. Depending on the ventilation of the left lung during surgery and the tidal volume (TV), it may affect postoperative atelectasis and may cause functional ventilation. This can lead to the occurrence of respiratory complications such as pneumonia after surgery, resulting in poor prognosis.
- Conditions
- Patients Who Underwent CPB for MICS
- Being tested
- Ventilation during cardiopulmonary bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation during cardiopulmonary bypassProcedure or surgery
Ventilation was performed using an inhaled oxygen fraction of 20% and a tidal volume of 5ml/kg at the time of cardiopulmonary bypass.
| Study group | Role | What they receive |
|---|---|---|
| Group N | No intervention | Stopping ventilation during cardiopulmonary bypass |
| Group V | Active comparator | Ventilation was performed using an inhaled oxygen fraction of 20% and a tidal volume of 5ml/kg at the time of cardiopulmonary bypass. Receives: Procedure: Ventilation during cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pulmonary ventilation disorders
Confirmation of postoperative pulmonary ventilation disorders according to the lung ventilation strategy at the time of cardiopulmonary bypass in minimally invasive cardiac surgery
Measured: after ICU transferring (up to 1hour)
Secondary outcomes (1)
incidence of postoperative pulmonary complications
the difference in the incidence of postoperative pulmonary complications according to the pulmonary ventilation strategy at the time of cardiopulmonary bypass in minimally invasive cardiac surgery
Measured: during ICU hospitalization (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start2 Aug 2021
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Who Underwent CPB for MICSStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung Gon Je, Pusan National University Yangsan Hospital
- Investigators
- Hyung Gon Je, Principal investigator, School of Medicone, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985513
- Sponsor's protocol ID
- 05-2021-156
- Status last verified
- Oct 2023
- First submitted
- 16 Jul 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yeo HJ, Kim HY, Je HG, Kim HJ, Park S, Yoon JP, Ju MH, Lim MH, Lee CH. Electrical impedance tomography-based evaluation of regional lung ventilation according to ventilation strategy during cardiopulmonary bypass in minimally invasive cardiac surgery: a prospective randomized controlled trial. J Thorac Dis. 2025 Jun 30;17(6):3912-3923. doi: 10.21037/jtd-24-1877. Epub 2025 Jun 23.
PubMed 40688333
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography Based Regional Lung Ventilation Evaluation According to Ventilation Strategy During Cardiopulmonary Bypass in Minimally Invasive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04985513
- Acronym / sponsor ID
- 05-2021-156
- Conditions
- Patients Who Underwent CPB for MICS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 2 Aug 2021 (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.
Electrical impedance tomography (EIT) is a non-invasive, radiation-free imaging technique that measures local pulmonary ventilation and ventilation distribution through potential changes on the skin surface of the chest wall during the respiratory cycle. Recently, a global inhomogeneity (GI) index has been proposed and used to quantify the distribution of tidal volume in the lungs. Currently, there are research results showing that ventilation improves postoperative oxygenation and gas exchange when ventilation is applied during CPB, but the evidence for long-term prognosis is lacking. In this study, researchers performed electrical impedance tomography in the intensive care unit immediately after surgery on patients who had undergone endotracheal tube extubation in the operating room immediately after completing minimally invasive cardiac surgery by collapsing the right lung through right minimal thoracotomy. The purpose of this study is to measure local pulmonary ventilation and ventilation distribution using this method and to find the optimal left lung ventilation method during minimally invasive cardiac surgery based on this. Identifying the difference in postoperative pulmonary ventilation disorders and functional regional ventilation according to the pulmonary ventilation strategy at the time of CPB in minimally invasive cardiac surgery can help predict the risk of pulmonary complications and improve the prognosis of patients after surgery.
Detailed description
Minimally invasive cardiac surgery (MICS) is a safe and effective surgical method that reduces bleeding, number of reoperations, postoperative pain, and length of stay in the ICU, and promotes faster recovery compared to conventional open thoracic cardiac surgery. In general, since cardiopulmonary bypass (CPB) is used during minimally invasive cardiac surgery using right thoracotomy, both lungs can be maintained in a lung rest state. Except for 2-3 ventilations when releasing the aortic forceps during surgery, there is no ventilation at all during CPB, and both lung ventilation starts when CPB is stopped. In order to secure the surgical field of view during surgery, most anesthetists do not ventilate the right lung and maintain a collapsed state. Even during CPB, ventilation can be performed without affecting the field of vision at the surgical site. However, to date, it is not well known about the proper ventilation method for the left lung during cardiac surgery using CPB.
Pulmonary complications are major postoperative complications of minimally invasive cardiac surgery and are factors that increase postoperative pulmonary complications, such as age, preoperative lung disease, and duration of CPB, which are well-known. Failure to ventilate the entire lung field at the time of CPB may cause atelectrauma, and even if normal ventilation is performed after CPB, and shearing force from repeated collapse and expansion of the atelectasis area may occur. In addition, such atelectasis can lead to not only ventilation disorders, ventilation/perfusion imbalances, but also postoperative pneumonia and poor prognosis. In particular, since right thoracotomy is mainly performed in minimally invasive cardiac surgery, the right lung collapses through one lung ventilation from the start of the operation to the access to the surgical site or at the end of the operation to check for bleeding at the surgical site. Therefore, one lung ventilation may be required even after weaning from the CPB, which may increase the risk of atelectasis in the operated side. Depending on the ventilation of the left lung during surgery and the tidal volume (TV), it may affect postoperative atelectasis and may cause functional ventilation. This can lead to the occurrence of respiratory complications such as pneumonia after surgery, resulting in poor prognosis.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group N | No intervention | –Stopping ventilation during cardiopulmonary bypass |
| Group V | Active comparator | Procedure: Ventilation during cardiopulmonary bypassVentilation was performed using an inhaled oxygen fraction of 20% and a tidal volume of 5ml/kg at the time of cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 18 years of age
- Patients who underwent one lung ventilation using a bronchial blocker for minimally invasive cardiac surgery
- If there is no atelectasis on chest X-ray or chest computed tomography performed before surgery
Key exclusion criteria (4 listed)
- If there is evidence of atelectasis, pneumonia, or lung disease that can reduce lung volume in a chest X-ray examination or chest computed tomography performed before surgery
- Patients scheduled for sternotomy
- If there is a skin disease in the chest that requires EIT measurement
- If there is a plan to transfer to the intensive care unit while maintaining the endotracheal tube
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 |
|---|---|---|
| Ventilation during cardiopulmonary bypassVentilation was performed using an inhaled oxygen fraction of 20% and a tidal volume of 5ml/kg at the time of cardiopulmonary bypass. | Procedure or surgery | Group V |
Primary outcome
postoperative pulmonary ventilation disorders
Time frame: after ICU transferring (up to 1hour)
Confirmation of postoperative pulmonary ventilation disorders according to the lung ventilation strategy at the time of cardiopulmonary bypass in minimally invasive cardiac surgery
1 secondary outcome
incidence of postoperative pulmonary complications
Time frame: during ICU hospitalization (up to 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 40688333Yeo HJ, Kim HY, Je HG, Kim HJ, Park S, Yoon JP, Ju MH, Lim MH, Lee CH. Electrical impedance tomography-based evaluation of regional lung ventilation according to ventilation strategy during cardiopulmonary bypass in minimally invasive cardiac surgery: a prospective randomized controlled trial. J Thorac Dis. 2025 Jun 30;17(6):3912-3923. doi: 10.21037/jtd-24-1877. Epub 2025 Jun 23.
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. This study is not recruiting at the moment.
Hyung Gon Je principal investigator
School of Medicone, Pusan National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation during cardiopulmonary bypass in people with Patients Who Underwent CPB for MICS, run by Pusan National University Yangsan Hospital 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 3 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: finished, as of the sponsor's last update on 10 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative pulmonary ventilation disorders (time frame: after ICU transferring (up to 1hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985513, which also lists 1 linked publication.
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 10 Oct 2023.