I-ASV in Cardiac Surgery (POSITiVE II)

Medical University of Vienna

Status: Enrolling

Conditions: Ventilator Lung

Treatments: Device: INTELLiVENT-ASV.

Study type: Interventional

Funder types: Other

Identifiers

NCT06178510

POSITiVE II v1.1

Details and patient eligibility

About

'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.

Full 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.

Enrollment: 328 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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328 participants in 2 patient groups

INTELLiVENT-ASV

Other group

Description:

The ventilator set parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation. The investigators monitor it and define clinical target.

Treatment:

Device: INTELLiVENT-ASV.

conventional ventilation

No Intervention group

Description:

The investigators set and monitor parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation.