Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery

NCT07612709 | Not Yet Recruiting

• 1 other identifier: EK Nr: 1250/2021
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Protective Ventilation; Cardiopulmonary Bypass; High-risk Cardiac Patients; Lung Ultrasound; Lung Water Assessment; Pulmonary Complications in Surgical Patients; Single-lung Ventilation; Chest X-ray for Clinical Evaluation; Electrical Impedance Tomography (EIT); Lung Compliance; Oxygenation Indices; Biomarkers of Vascular Endothelial Injury

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  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.

  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).

  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.

  Assessed on the day of surgery and on day 1 and 2 after surgery.

• Static lung compliance determined in each lung separately.

  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.

Other Outcomes (4)

• Length of ICU and hospital stay.

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

• In-hospital mortality.

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

• Duration on respiratory support via endotracheal tube.

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

Study Arms (1)

Risk group

ACTIVE COMPARATOR

Lung ventilated during cardiopulmonary bypass using single-lung ventilation via double-lumen tube.

Procedure: Ventilated lung; Procedure: Non-ventilated lung.

Interventions

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%.

Risk group

Non-ventilated lung. PROCEDURE

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

Risk group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

General Hospital Vienna

Vienna, State of Vienna, 1090, Austria

Location

Study Officials

• Martin Dworschak, MD, MBA

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Dworschak, MD, MBA

CONTACT

+43-1-40400; martin.dworschak@meduniwien.ac.at

Edda M. Tschernko, MD, MBA

CONTACT

+43-1-40400; edda.tschernko@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ao.Univ. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)