Lung Protective VentilationNCT07612709
Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery
A study testing Ventilated lung and Non-ventilated lung. in people with Lung Protective Ventilation and Cardiopulmonary Bypass, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study investigates if single lung ventilation on cardiopulmonary bypass can mitigate postoperative lung water accumulation determined by lung ultrasound in the ventilated lung as compared to the non-ventilated lung in patients at high-risk for developing severe pulmonary complications after cardiac surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lung Protective Ventilation, Cardiopulmonary Bypass, High-risk Cardiac Patients
- What is being tested?
- Ventilated lung and Non-ventilated lung.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2026to 31 Jul 2029
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients at increased risk for postoperative pulmonary complications
- Major elective cardiac surgery
- Prolonged duration of cardiopulmonary bypass
- Patients older than 65 years of age
- Informed consent
Who cannot join
- Emergency
- Urgent procedures
- Patients with implanted pacemakers
- Patients with internal cardioverter/defibrillators
- Decompensated cardiac disease
- Pulmonary disease
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- Recent pneumonia
- Need for temporary perioperative mechanical support
- Patients not willing to participate
- Treatment with inhaled nitric oxide
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
General Hospital Vienna
Vienna, State of Vienna, 1090
Martin Dworschak, MD, MBA, +43-1-40400 ext. 41090, martin.dworschak@meduniwien.ac.at
Edda M. Tschernko, MD, MBA, +43-1-40400 ext. 41060, edda.tschernko@meduniwien.ac.at
About this study
Official title: Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery in Patients at Increased Risk for Severe Postoperative Pulmonary Complications
This study investigates if single lung ventilation on cardiopulmonary bypass can mitigate postoperative lung water accumulation determined by lung ultrasound in the ventilated lung as compared to the non-ventilated lung in patients at high-risk for developing severe pulmonary complications after cardiac surgery.
- Conditions
- Lung Protective Ventilation, Cardiopulmonary Bypass, High-risk Cardiac Patients, Lung Ultrasound, Lung Water Assessment, Pulmonary Complications in Surgical Patients
- Being tested
- Ventilated lung, Non-ventilated lung.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilated lungProcedure or surgery
This lung will be ventilated during cardiopulmonary bypass using volume-controlled ventilation with a tidal volume of 3 mL/kg ideal body weight, a PEEP of 5 cmH2O, a respiratory rate of 10/min, and a fraction of inspired oxygen of 30%.
Non-ventilated lung.Procedure or surgery
The contralateral lung will not be ventilated during cardiopulmonary bypass and will be allowed to collapse.
| Study group | Role | What they receive |
|---|---|---|
| Risk group | Active comparator | Lung ventilated during cardiopulmonary bypass using single-lung ventilation via double-lumen tube. Receives: Procedure: Ventilated lung; Procedure: Non-ventilated lung. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung aeration score of both lungs.
The aeration score of each lung is the sum of the aeration scores determined in each of six lung quadrants in each lung, which can range from 0 (normal ventilation) to 3 (atelectasis/consolidation).
Measured: Lung ultrasound investigations will be performed at baseline, i.e., before surgery, on the day of surgery, and on day 1 and 2 after surgery in the intensive care unit.
Secondary outcomes (6)
Radiologic assessment of Kerley B lines as indicators of lung edema.
Number of Kerley B lines in both lungs determined by chest x-ray where stage 1 (no Kerley B lines) reflects best outcome, stage 2 (Kerley B lines become visible) indicates interstitial edema, and stage 3 (increased number of Kerley B lines also in non-dependent areas and partially obscured in dependent parts of the lung) are a sign of alveolar edema.
Measured: Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
Presence of pleural effusion in chest x-ray.
Severity assessment will be semi-quantitative with 0 = no effusion, 1 = small effusion (with blunting of the basal lung segments and the costophrenic angle), 2 = moderate effusion (fluid extents to the mid-hemithorax creating a "meniscus sign"), and 3 = massive effusion (the whole lung appears opaque with displacement of the heart to the contralateral side if located unilaterally).
Measured: Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
Determination of the Global Inhomogeneity (GI) index in both lungs separately by thoracic Electrical Impedance Tomography (EIT).
Global inhomogeneity is calculated as the sum of the absolute differences between the median value of tidal variation and every single pixel value, divided by the sum of all impedance values, to normalize the calculated values. A GI index closer to 0 represents highly homogeneous (even) ventilation. Higher values (i.e., > 0.5) indicate that some parts of the lung are over-distended while others are poorly aerated or collapsed (atelectasis).
Measured: On the day of surgery and on day 1 and 2 after surgery in the intensive care unit.
Worst oxygenation (Horowitz) index measured per day during routine blood gas checks.
The Horowitz index (HI) is calculated by diving arterial oxygen partial pressure determined in the blood gas by the fraction of inspired oxygen. It will be assessed after each blood gas check and the lowest HI during one day will be entered for further statistical analysis. The degree of impaired lung function will be determined as follows: HI > 300 mmHg (healthy lung function), HI between 201-300 mmHg (mild lung injury), HI between 101-200 mmHg (moderately severely impaired lung function), and HI < 100 mmHg (severe lung injury, ARDS).
Measured: Assessed on the day of surgery and on day 1 and 2 after surgery.
Static lung compliance determined in each lung separately.
Static lung compliance of the ventilated and the non-ventilated lung will be determined twice for each patient. Static compliance in healthy adults ranges between 60 and 100 mL/cm H₂O. Values below 50 mL/cm H₂O would be considered abnormally low.
Measured: On the day of surgery in the operating room before and after cardiac surgery on cardiopulmonary bypass when the patient is still ventilated via double lumen tube.
Amount of released immune modulators.
Serum levels for HSP70, MMP-8, MMP-9, TIMP-1, and Lipocalin-2 will be determined in patients' blood samples, with normal values ranging from 0.2-3 ng/mL for HSP70, 0.3-1.2 ng/mL for MMP-8, 14-100 ng/mL for MMP-9, 80-150 ng/mL for TIMP-1, and 20-130 ng/mL for Lipocalin-2, respectively.
Measured: Determined on the day of surgery as well as on day 1, 2, 3, and 4 after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Protective VentilationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- With single-lung ventilation with a double lime tube during cardiopulmonary bypass each patient will be her own control, i.e., the lung that had been ventilated can be compared with the contralateral lung that had not been ventilated during the bypass run.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Martin Dworschak, Medical University of Vienna
- Investigators
- Martin Dworschak, MD, MBA, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612709
- Sponsor's protocol ID
- EK Nr: 1250/2021
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The primary reason for not sharing IPD is the protection of patient privacy.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery in Patients at Increased Risk for Severe Postoperative Pulmonary Complications
- ClinicalTrials.gov ID
- NCT07612709
- Acronym / sponsor ID
- EK Nr: 1250/2021
- Conditions
- Lung Protective Ventilation, Cardiopulmonary Bypass, High-risk Cardiac Patients, Lung Ultrasound, Lung Water Assessment, Pulmonary Complications in Surgical Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 29 May 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 if single lung ventilation on cardiopulmonary bypass can mitigate postoperative lung water accumulation determined by lung ultrasound in the ventilated lung as compared to the non-ventilated lung in patients at high-risk for developing severe pulmonary complications after cardiac surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- With single-lung ventilation with a double lime tube during cardiopulmonary bypass each patient will be her own control, i.e., the lung that had been ventilated can be compared with the contralateral lung that had not been ventilated during the bypass run.
| Arm | Type | Receives |
|---|---|---|
| Risk group | Active comparator | Procedure: Ventilated lung, Procedure: Non-ventilated lung.Lung ventilated during cardiopulmonary bypass using single-lung ventilation via double-lumen tube. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients at increased risk for postoperative pulmonary complications
- Major elective cardiac surgery
- Prolonged duration of cardiopulmonary bypass
- Patients older than 65 years of age
- Informed consent
Key exclusion criteria (10 listed)
- Emergency
- Urgent procedures
- Patients with implanted pacemakers
- Patients with internal cardioverter/defibrillators
- Decompensated cardiac disease
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 |
|---|---|---|
| Ventilated lungThis lung will be ventilated during cardiopulmonary bypass using volume-controlled ventilation with a tidal volume of 3 mL/kg ideal body weight, a PEEP of 5 cmH2O, a respiratory rate of 10/min, and a fraction of inspired oxygen of 30%. | Procedure or surgery | Risk group |
| Non-ventilated lung.The contralateral lung will not be ventilated during cardiopulmonary bypass and will be allowed to collapse. | Procedure or surgery | Risk group |
Primary outcome
Lung aeration score of both lungs.
Time frame: Lung ultrasound investigations will be performed at baseline, i.e., before surgery, on the day of surgery, and on day 1 and 2 after surgery in the intensive care unit.
The aeration score of each lung is the sum of the aeration scores determined in each of six lung quadrants in each lung, which can range from 0 (normal ventilation) to 3 (atelectasis/consolidation).
6 secondary outcomes
Radiologic assessment of Kerley B lines as indicators of lung edema.
Time frame: Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
Presence of pleural effusion in chest x-ray.
Time frame: Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
Determination of the Global Inhomogeneity (GI) index in both lungs separately by thoracic Electrical Impedance Tomography (EIT).
Time frame: On the day of surgery and on day 1 and 2 after surgery in the intensive care unit.
Worst oxygenation (Horowitz) index measured per day during routine blood gas checks.
Time frame: Assessed on the day of surgery and on day 1 and 2 after surgery.
Static lung compliance determined in each lung separately.
Time frame: On the day of surgery in the operating room before and after cardiac surgery on cardiopulmonary bypass when the patient is still ventilated via double lumen tube.
Amount of released immune modulators.
Time frame: Determined on the day of surgery as well as on day 1, 2, 3, and 4 after surgery.
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 29 May 2026.
- Individual participant dataSharing planned: No. The primary reason for not sharing IPD is the protection of patient privacy.
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Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
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Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
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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.
Martin Dworschak, MD, MBA principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilated lung and Non-ventilated lung. in people with Lung Protective Ventilation and Cardiopulmonary Bypass, run by Medical University of Vienna at 1 site in Austria.
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 10 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 29 May 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 Austria. 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 Martin Dworschak, MD, MBA (+43-1-40400 ext. 41090, martin.dworschak@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung aeration score of both lungs. (time frame: Lung ultrasound investigations will be performed at baseline, i.e., before surgery, on the day of surgery, and on day 1 and 2 after surgery in the intensive care unit.). 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 29 May 2026.