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NCT Number: NCT07612709

Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital Vienna

Vienna, State of Vienna, 1090, Austria

Location contact

Edda M. Tschernko, MD, MBA

CONTACT

[email protected]

+43-1-40400 ext. 41060

Edda M. Tschernko, MD, MBA

SUB_INVESTIGATOR

Florentina Zingher, MD

SUB_INVESTIGATOR

Keso Skhirtladze-Dworschak, MD

SUB_INVESTIGATOR

Martin Dworschak, MD, MBA

CONTACT

[email protected]

+43-1-40400 ext. 41090

Martin Dworschak, MD, MBA

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Emergency
  • Urgent procedures
  • Patients with implanted pacemakers
  • Patients with internal cardioverter/defibrillators
  • Decompensated cardiac disease
  • Pulmonary disease
  • Recent pneumonia
  • Need for temporary perioperative mechanical support
  • Patients not willing to participate
  • Treatment with inhaled nitric oxide

Treatment and study plan

Ventilated lung

Procedure

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

The contralateral lung will not be ventilated during cardiopulmonary bypass and will be allowed to collapse.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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).

  3. 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.

    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).

  4. 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.

    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).

  5. 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.

    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.

  6. 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.

    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.

Other outcomes

  1. Length of ICU and hospital stay.

    Time frame: These variables will be censored at study completion, on average 30 days.

    The duration from transfer to the intensive care unit until discharge to a step-down unit and the duration of hospitalization of the patient will be determined in days.

  2. In-hospital mortality.

    Time frame: In-hospital mortality will be censored at study completion, on average 30 days.

    It will be recorded if the patient has been discharged from the hospital alive.

  3. Duration on respiratory support via endotracheal tube.

    Time frame: The time until extubation will be censored at study completion, on average 30 days.

    The hours between arrival of the intubated patient on the intensive care unit until extubation will be determined.

  4. Postoperative complications.

    Time frame: All complications will be censored at study completion, on average 30 days.

    Any complication that poses a risk for the patient occurring during the hospital stay and having been documented in the patient's file will be retrieved by carefully reviewing the files and recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Edda M. Tschernko, MD, MBA

CONTACT

[email protected]

+43-1-40400 ext. 41060

Martin Dworschak, MD, MBA

CONTACT

[email protected]

+43-1-40400 ext. 41090

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery in Patients at Increased Risk for Severe Postoperative Pulmonary Complications

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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