I-ASV in Cardiac Surgery

Launched by MEDICAL UNIVERSITY OF VIENNA · Dec 20, 2023

Keywords

ClinConnect Summary

The POSITiVE II trial is studying a new way to help patients breathe after cardiac surgery using a method called adaptive support ventilation. This trial is for adults over 18 who are scheduled to have elective heart surgery, such as bypass surgery or valve replacement, and who will need help breathing in the intensive care unit (ICU) for more than 2 hours after their surgery. Unfortunately, people with certain medical conditions or those undergoing emergency surgeries cannot participate.

If you or a family member qualify for this trial, you will receive the usual care for your breathing needs, along with the possibility of the new adaptive support method. The trial aims to see if this new approach can improve recovery after surgery. Participants will be closely monitored, and it's important to understand that your safety and comfort are the top priorities throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. aged \> 18 years of age;
• • 2. scheduled for elective cardiac surgery; and
• • 3. expected to receive postoperative ventilation in the ICU for \> 2 hours.
• Exclusion Criteria:
• • 1. any emergency or semi-elective surgery (precluding informed written consent);
• • 2. any surgery other than CABG, valve replacement or repair, or a combination (i.e., patients planned for surgery for congenital heart disease, or scheduled for heart transplantation are excluded);
• • 3. enrolled in another interventional trail;
• • 4. no written informed consent obtained;
• • 5. history of recent pneumectomy or lobectomy;
• • 6. history of COPD with oxygen at home;
• • 7. body mass index \> 35;
• • 8. preoperative forced expiratory volume in the first second (FeV1)/forced vital capacity (VC) \< 50% (if available);
• • 9. preoperative arterial oxygen partial pressure (PaO2) \< 60 mm Hg (at room air);
• • 10. preoperative arterial carbon dioxide partial pressure (PaCO2) \> 50 mm Hg;
• • 11. preoperative left ventricular ejection fraction \< 30% (if available);
• • 12. preoperative systolic pulmonary artery pressure \> 60 mm Hg (if available);
• • 13. preoperative left ventricular mechanical support, e.g., Impella®; or
• • 14. preoperative use of veno-venous or veno-arterial extracorporeal support
• At the end of surgery, patients are additionally excluded if a patient:
• • 15. cannot be weaned from the extracorporeal support; or
• • 16. unexpectedly needs implementation of an assist device