RecruitingNot ApplicableNCT06178510

I-ASV in Cardiac Surgery

POStoperative INTELLiVENT-adaptive Support VEntilation in Cardiac Surgery Patients II (POSITiVE II) - a Randomized Clinical Trial

Sponsor

Medical University of Vienna

Enrollment

328 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

Ventilator Lung

Summary

'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.

Eligibility

Min Age: 18 YearsMax Age: 120 Years

Inclusion Criteria3

\. aged \> 18 years of age;
\. scheduled for elective cardiac surgery; and
\. expected to receive postoperative ventilation in the ICU for \> 2 hours.

Exclusion Criteria17

any emergency or semi-elective surgery (precluding informed written consent);
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);
enrolled in another interventional trail;
no written informed consent obtained;
history of recent pneumectomy or lobectomy;
history of COPD with oxygen at home;
body mass index \> 35;
preoperative forced expiratory volume in the first second (FeV1)/forced vital capacity (VC) \< 50% (if available);
preoperative arterial oxygen partial pressure (PaO2) \< 60 mm Hg (at room air);
preoperative arterial carbon dioxide partial pressure (PaCO2) \> 50 mm Hg;
preoperative left ventricular ejection fraction \< 30% (if available);
preoperative systolic pulmonary artery pressure \> 60 mm Hg (if available);
preoperative left ventricular mechanical support, e.g., Impella®; or
preoperative use of veno-venous or veno-arterial extracorporeal support
At the end of surgery, patients are additionally excluded if a patient:
cannot be weaned from the extracorporeal support; or
unexpectedly needs implementation of an assist device

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Interventions

DEVICEINTELLiVENT-ASV.

INTELLiVENT-ASV® is a closed-loop ventilation mode that automatically adjusts respiratory rate and tidal volume according to the oxygen and ventilatory patient needs