I-ASV in Cardiac Surgery

Overview

'POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II) is an investigator-initiated, international, multicenter, parallel, randomized clinical trial in patients after cardiac surgery.

Description

To compare INTELLiVENT-ASV with conventional ventilation with respect to (i.) quality of ventilation; and (ii.) ICU nursing staff workload in an international cohort of participants receiving postoperative ventilation after cardiac surgery. This study will also determine the effects of INTELLiVENT-ASV on clinical outcomes, including (iii.) duration of postoperative ventilation and (iv.) length of stay in ICU.

Eligibility

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