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Not yet recruiting NCT07612709

Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery

No phase Interventional Lung Protective Ventilation Cardiopulmonary Bypass High-risk Cardiac Patients Lung Ultrasound

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ventilated lung, Non-ventilated lung..
Who it may be relevant to
Registry conditions: Lung Protective Ventilation, Cardiopulmonary Bypass, High-risk Cardiac Patients, Lung Ultrasound. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Ventilated lung
    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%.
  • Procedure Non-ventilated lung.
    The contralateral lung will not be ventilated during cardiopulmonary bypass and will be allowed to collapse.

Primary outcome measures

  • 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.]
Secondary outcome measures (6)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Austria · 1 center
  • General Hospital Vienna — Vienna

Identifiers

NCT: NCT07612709 · EK Nr: 1250/2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗